Can You Get Semaglutide Without a Doctor Visit? What the Rules Really Say
Semaglutide For Weight Loss
If you’re searching for semaglutide for weight loss near me in Laguna Beach, the information online can feel overwhelming. Some sites suggest a quick online quiz is enough, while others stress the need for a prescription and medical supervision. The truth is that semaglutide is a prescription medication in the United States. You cannot legally obtain FDA-approved semaglutide for weight loss without a prescription from a licensed medical professional. That said, the process does not need to be difficult. Many people start with a telehealth visit, basic lab work, and a personalized plan without hours in a clinic.
What is semaglutide and how does it work?
Semaglutide belongs to a class of medications called GLP-1 receptor agonists. It mimics a natural hormone that regulates appetite and digestion. This means it helps the brain feel full sooner, slows stomach emptying, and reduces spikes in blood sugar. The result is less hunger, fewer cravings, and a better chance of sticking with balanced meals. First used for type 2 diabetes, semaglutide was later approved for chronic weight management at higher doses.
Treatment usually involves a once-weekly injection. Doses start low and gradually increase, allowing the body to adjust and reducing nausea, the most common side effect. Many patients describe a quieting of “food noise”—less drive to snack and smaller portions feeling satisfying. Over time, this translates to steady weight loss, especially when paired with protein-rich meals, hydration, and moderate activity.
Is semaglutide prescription-only?
Yes. FDA-approved semaglutide products require a prescription:
Wegovy: Approved for chronic weight management in adults with a BMI of 30 or higher, or 27 with a weight-related condition such as high blood pressure or prediabetes.
Ozempic: Approved for type 2 diabetes. Sometimes prescribed off-label for weight loss when clinically appropriate.
There is no over-the-counter semaglutide. Any vendor offering semaglutide without a prescription is unsafe. Counterfeit products and mislabeled doses are common risks.
Can semaglutide be prescribed without an in-person visit?
Yes, in many cases. Telemedicine visits are legally allowed in California if they include a full medical evaluation. This means a live video appointment, a review of medical history and medications, and usually baseline lab work. A short form without a clinician’s review does not meet prescribing standards. Some patients start virtually, complete labs, and receive their medication by pickup or mail. Others prefer an in-person visit for their first injection and training.
What about compounded semaglutide?
Compounded semaglutide is prepared by compounding pharmacies, sometimes used during shortages or when brand-name products are unaffordable. However, quality varies:
FDA-approved semaglutide remains the standard, as it is batch-tested and standardized.
Some compounded products use semaglutide salts that differ from the approved active ingredient, raising concerns about effectiveness and safety.
Only state-licensed pharmacies with transparent sourcing and certificates of analysis should be considered.
Patients have reported issues with under-dosed or mislabeled compounded products, leading to poor results or unexpected side effects. Verified sources are essential for safety and progress.
What are the rules in California?
In California, clinicians prescribing semaglutide must establish a legitimate patient relationship. This includes:
Obtaining medical history and medication review.
Screening for contraindications such as thyroid cancer history or pancreatitis.
Providing counseling on dosing, side effects, and missed doses.
Arranging follow-up care to monitor safety and progress.
Why supervision matters
Most healthy adults tolerate semaglutide well, but problems arise with rushed dosing or poor-quality medication. Common issues include:
Nausea and vomiting from dose increases that are too fast.
Dehydration from reduced hunger and thirst.
Low blood sugar in patients using diabetes medications without adjustments.
Gallbladder flare-ups in people with prior gallstones.
Persistent constipation or reflux if left unmanaged.
With proper pacing, lab monitoring, and symptom management, side effects can often be minimized while weight loss continues steadily.
What makes a safe program?
A structured semaglutide program typically includes:
Screening for medical history and contraindications.
Baseline labs such as metabolic panel, A1c, and thyroid function.
A clear titration schedule with flexibility to pause or adjust.
Strategies for managing side effects like nausea or constipation.
Regular check-ins to track weight loss, appetite, and lab results.
Will insurance cover semaglutide?
Coverage varies widely. Some plans cover Wegovy for weight management with prior authorization. Others exclude weight loss drugs entirely. Ozempic is more often covered for type 2 diabetes. If coverage is denied, patients often turn to cash-pay programs or compounded versions as more affordable alternatives. Transparent cost discussions are key to planning treatment.
How quickly does weight loss occur?
Results vary, but clinical studies show average losses of 10–15% of starting body weight over 12–16 months. Typically:
Month 1: Lower doses, appetite begins to decrease.
Months 2–3: Visible changes in weight and portion sizes.
Months 4–6: More consistent results, often 5–10% total body weight reduction.
Non-scale benefits—better sleep, less joint strain, and improved energy—often appear early and help patients stay motivated.
Can semaglutide be stopped?
Yes, but appetite often returns. To maintain results, tapering and reinforcing healthy habits are recommended. Some patients stay on a low maintenance dose, while others stop entirely and continue with diet and activity changes. A planned exit strategy helps reduce weight regain.
Red flags when choosing online providers
Warning signs of unsafe services include:
No live medical visit or only a checkbox form.
No lab work requested.
Vague medication source or mention of “semaglutide salts.”
Aggressive dosing without flexibility.
No local contact for support if side effects occur.
Side effect management
Most side effects can be managed with small adjustments:
Constipation: Hydration, fiber, magnesium, and light walking.
Reflux: Avoid late-night heavy meals; temporary acid-reducing medication if needed.
Fatigue: Adequate protein, rest, and hydration.
What if weight loss plateaus?
Plateaus are common. They can often be addressed by improving protein intake, hydration, sleep quality, or adding short walks after meals. Lab work may also identify thyroid or metabolic issues. Increasing the dose is not always the solution; sometimes lifestyle adjustments work better.
Why local care in Laguna Beach helps
Local care means easier access to safe medication, faster response if issues arise, and support from providers familiar with the community. It also helps patients stick to a routine that fits their real-life schedules, whether that’s early morning walks on the beach or managing busy workdays.
How to get started with semaglutide injections near Laguna Beach
To begin treatment safely:
Schedule a consultation, either in person or via telehealth.
Complete basic labs to confirm safety for treatment.
Receive a clear plan with dose schedule and side effect strategies.
Learn self-injection technique or receive initial injections in-clinic.
Check in regularly to track results and make adjustments.
Key takeaways
Semaglutide is a prescription-only medication for weight loss.
Safe programs include medical history, labs, dosing plans, and follow-up.
Costs range widely, with compounded options often more affordable than brand-name pens.
Insurance coverage is inconsistent and often requires prior authorization.
Steady progress is most likely with professional oversight and simple lifestyle support.
If you’re searching for “Semaglutide injection for weight loss near me” in Laguna Beach, prioritize safety, verified medication, and ongoing support. With the right guidance, semaglutide can be a safe and effective tool for steady weight loss and improved overall health.
In combination with a reduced calorie diet and increased physical activity, semaglutide (as Wegovy) is also indicated in the US for reducing the risk of major adverse cardiovascular events (cardiovascular death, myocardial infarction, or stroke) in adults with established cardiovascular disease and who are either obese or overweight,[15] for reducing excess body weight and maintaining weight reduction long term in obese individuals twelve years of age or older, and for overweight adults with at least one weight-related comorbid condition.[15][34][35] After stopping semaglutide, individuals on average regain about two-thirds (67%) of the weight they lost during treatment within the following year.[36][37]
In October 2025, the US FDA further expanded the indication for semaglutide (as Rybelsus) to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type2 diabetes who are at high risk for these events.[14][38]
In the EU, semaglutide is indicated for the treatment of adults with insufficiently controlled type2 diabetes as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance or contraindications,[16][17] in addition to other medicinal products for the treatment of diabetes.[16][17]
In the EU, semaglutide (as Wegovy) is further indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with obesity (initial BMI ≥ 30 kg/m2) or who are overweight (initial BMI ≥ 27 kg/m2) and have at least one weight-related comorbidity such as dysglycemia (pre-diabetes or type2 diabetes), hypertension, dyslipidemia, or cardiovascular disease.[18] It is also indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents (aged twelve years of aged and older) with obesity and body weight above 60 kg (130 lb).[18]
GLP-1 regulates digestion and blood sugar. The small intestine releases GLP-1 when food is eaten. It reduces hunger, signals fullness, stimulates insulin, and inhibits glucagon, maintaining glucose levels.
Semaglutide is a glucagon-like peptide-1 receptor agonist.[13][14][15] The drug decreases blood sugar levels. The decrease is theorized to be caused by the mimicking of glucagon-like peptide-1 (GLP-1), an incretin.[45] It also appears to enhance growth of pancreatic beta cells, which are responsible for insulin production and release.[27][46] Additionally, it inhibits the production of glucagon, the hormone that increases glycogenolysis (release of stored carbohydrate from the liver) and gluconeogenesis (synthesis of new glucose). It reduces food intake by lowering appetite and slowing down digestion in the stomach,[26] helping reduce body weight.[47][48]
Schematic representation of the structures of semaglutide and liraglutide, compared to GLP-1
Semaglutide is chemically similar to human GLP-1.[49] The first six amino acids of GLP-1 are missing.[49] Substitutions are made at GLP positions 8 and 34 (semaglutide positions 2 and 28), where alanine and lysine are replaced by 2-aminoisobutyric acid and arginine, respectively.[49] The substitution of the alanine prevents chemical breakdown by dipeptidyl peptidase-4.[50] The lysine at GLP position 26 (semaglutide position 20) has a long chain attached, ending with a chain of 18 carbon atoms and a carboxyl group.[50] This increases the drug's binding to blood protein (albumin), which enables longer presence in the blood circulation.[50]
Semaglutide's half-life in the blood is about seven days (165–184 hours).[27][51]
In the 1970s, Jens Juul Holst and Joel Habener began research on the GLP-1 hormone, initially in relation to duodenal ulcer disease.[52] They were examining hormones secreted during eating, and testing them on pig pancreases, leading to the discovery of GLP-1's significant potency in 1988. Their work, which later contributed significantly to diabetes and obesity treatments, earned them and Daniel J. Drucker the 2021 Warren Alpert Foundation Prize.[52]
Research continued, and in 1993, Michael Nauck managed to infuse GLP-1 into people with type2 diabetes, stimulating insulin while inhibiting glucagon and bringing blood glucose to normal levels. However, treating diabetes with GLP-1 hormones resulted in significant side effects, leading researchers financed by Novo Nordisk to start looking to develop a suitable compound for therapeutic use.[52] In 1998, a team of researchers at Novo Nordisk led by Lotte Bjerre Knudsen developed liraglutide, a glucagon-like peptide-1 receptor agonist that could be used to treat diabetes.[53] This was followed by the development of semaglutide by a team of researchers at Novo Nordisk, including Jesper Lau, Thomas Kruse, and Paw Bloch.[54][55][56]
In June 2008, a phase II clinical trial began studying semaglutide, a once-weekly diabetes therapy as a longer-acting alternative to liraglutide.[57][58] It was given the brand name Ozempic. Clinical trials started in January 2016 and ended in May 2017.[23][59]
The US Food and Drug Administration (FDA) approved semaglutide based on evidence from seven clinical trials of 4087 participants with type2 diabetes.[42] The trials were conducted at 536 sites in 33 countries, including Canada, Mexico, Russia, Ukraine, Turkey, India, South Africa, Japan, Hong Kong, multiple European countries, Argentina, and the United States.[42] In two of these trials (NCT02054897[60] and NCT02305381[61]), participants were randomly assigned to receive either semaglutide or placebo injection weekly.[42] Neither the participant nor the health care provider knew which treatment was being given until after the trials were completed.[42] Treatment was given for 30 weeks.[42] In the other five trials (NCT01930188,[62] NCT01885208,[63] NCT02128932,[64] NCT02207374,[65] and NCT02254291[66]), participants were randomly assigned to receive either semaglutide or another anti-diabetic medication, and the participant and provider knew which medication was being given in four trials.[42] Treatment was given for 30 weeks or 56 weeks.[42] In each trial, HbA1c was measured from the start of the trial to the end of the trial and compared between the semaglutide group and the other groups.[42]
The FDA also considered data from one separate trial (NCT01720446[67]) of 3297 participants with type2 diabetes who were at high risk for cardiovascular events.[42] This trial was conducted in 20 countries: multiple European countries, Russia, Turkey, Brazil, Israel, Malaysia, Mexico, Thailand, Taiwan, Canada, and the United States.[42] The participants were randomly assigned to receive semaglutide or placebo.[42] Neither the participant nor the health care provider knew which treatment was being given.[42] Treatment was given for 104 weeks (2 years), and the occurrence of cardiovascular events, including heart attacks, strokes, and hospitalization due to unstable angina (near heart attack) were recorded and compared in the two groups of participants.[42]
In March 2021, in a phase III randomized, double-blind trial, 1,961 adults with a body mass index of 30 or greater were assigned in a 2:1 ratio to a treatment with once-weekly subcutaneous semaglutide or placebo, plus lifestyle intervention. The trials occurred at 129 sites in 16 countries in Asia, Europe, North America, and South America. The mean percentage change in body weight at week 68 was −14.9% in the semaglutide group vs −2.4% with placebo, for an estimated treatment difference of −12.4 percentage points (95% CI, −13.4 to −11.5).[68][69][70][71]
A 2022 review of anti-obesity treatments found that semaglutide as well as tirzepatide (which has an overlapping mechanism of action) were more promising than previous anti-obesity drugs, although less effective than bariatric surgery.[72]
In March 2024, the US Food and Drug Administration expanded the indication for semaglutide (brand name Wegovy) to reduce the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and who are either obese or overweight.[35] The efficacy and safety of semaglutide for this indication were studied in a multi-national, multi-center, placebo-controlled double-blind trial that randomly assigned over 17,600 participants to receive either semaglutide (Wegovy) or placebo.[35] Participants in both groups also received standard-of-care medical treatment (e.g., management of blood pressure and cholesterol) and healthy lifestyle counseling (including diet and physical activity).[35] Semaglutide (Wegovy) significantly reduced the risk of major adverse cardiovascular events (cardiovascular death, heart attack, and stroke), which occurred in 6.5% of participants who received semaglutide (Wegovy) compared to 8% of participants who received placebo.[35]
In December 2016, a new drug application was filed with the US Food and Drug Administration (FDA), and in October 2017, a FDA advisory committee approved it unanimously.[73] In December 2017, the injectable version with the brand name Ozempic was approved in the US for use by people with diabetes,[30][74] and, in January 2018, in Canada.[75] In February 2018, authorization was granted in the European Union,[16][76] in March 2018 in Japan,[77] and in August 2019 in Australia.[1][3]
A version of semaglutide to treat diabetes that can be taken orally (Rybelsus) was approved for medical use in the US in September 2019,[78][79] and in the European Union in April 2020.[17] In January 2023, the US FDA prescription label for Rybelsus was updated to reflect that it can be used as a first-line treatment for adults with type2 diabetes.[80]
In June 2021, a higher-dose version for injectable use, sold under the brand name Wegovy, was approved by the FDA as an anti-obesity medication for long-term weight management in adults.[15] In January 2022, Wegovy was approved for medical use in the European Union.[18][21]
Due to high costs, some health plans in the US do not cover weight-loss drugs like semaglutide and tirzepatide.[81][82][83] In the United States, as of 2024, about half of private employer-sponsored plans cover these drugs,[84] Federal Medicare Part D does not cover weight-loss drugs, and only a few federally-funded, state-administered Medicaid plans do so.[85]
Semaglutide is expected to become patent-free in the United States no earlier than December 2031,[86] and in Europe and Japan in that same year.[87] The Chinese patent was scheduled to expire in 2026, but a court ruled in 2022 that all patents on semaglutide were invalid. Novo Nordisk appealed the ruling.[88] In Brazil, the Supreme Court refused to extend semaglutide's patent protection, which expires in 2026.[89] In Canada, Novo Nordisk failed to pay a required patent maintenance fee and the semaglutide patent will expire in January 2026.[87] Four companies, including Apotex, Sandoz, and Hims & Hers Health are expected to release generic versions of semaglutide in Canada.[90][91][92]
Semaglutide had the highest earnings from sales of medications in the US in 2023, with expenditures of US$38.6 billion.[93]
In the US, Wegovy has a list price of $1,349.02 per month as of 2022, suggesting that because of the high costs many people "who could most benefit from weight loss may be unable to afford such expensive drugs".[94] High costs of Ozempic prompted some insurance companies to investigate and refuse to cover individuals with what the companies considered was insufficient evidence to support a diabetes diagnosis, alleging off-label prescribing for weight loss.[95] In 2023, Ozempic, the semaglutide injection used for type 2 diabetes treatment, had list price of one-month supply of $936 in the US, $169 in Japan, $147 in Canada, $144 in Switzerland, $103 in Germany and the Netherlands, $96 in Sweden, $93 in the UK, and $87 in Australia; France had the lowest price at $83.[96][97]
In the UK, semaglutide is available on NHS prescription for diabetes at nominal or no cost to the individual.[98] It is also available for obesity, limited to treatment for two years.[99] In Finland, semaglutide is included in the national price regulation scheme and is available by prescription; however, for people with type 2 diabetes and a BMI over 27, part of the cost is covered by Kela, the Finnish Social Insurance Institution.[100] In Australia, semaglutide is available on the Pharmaceutical Benefits Scheme prescription for diabetes at the regular co-payment rates of $31.60, or $7.70 for concession card holders.[101]
High demand caused worldwide supply shortages of semaglutide in 2023;[95] new UK prescriptions were not issued during the shortage. Novo Nordisk revealed in April 2024, that to meet the enormous demand for semaglutide, it was running its production facilities 24/7; it had budgeted $6 billion in 2024 to expand its crowded and congested facilities; and it had hired over 10,000 new employees in 2023 alone.[102]
By 2023, Novo Nordisk had become the most valuable corporation in the European Union, worth more than US$500 billion, and accounted for almost all recent economic growth in Denmark.[103] The large amounts of foreign currency earned by Novo Nordisk from Wegovy and Ozempic sales, when converted to Danish krone, have generally exerted substantial upward pressure on the value of the krone, making it necessary for Danmarks Nationalbank to maintain lower interest rates than the European Central Bank.[104][105] Poor clinical trial results published by Novo Nordisk in December 2024 contributed to a drop in the krone's value.[106]
Profits from Novo Nordisk generate returns for the Novo Nordisk Foundation, which holds the controlling stake in Novo Nordisk. The profits results in increased Danish tax revenues and employment. Novo Nordisk added 3,500 jobs in Denmark in 2022, bringing the total in the country to 21,000 employees, out of 59,000 worldwide.[107]
In October 2023, there were reports of counterfeit Ozempic pens being sold in Europe.[108] The pens possibly contained insulin, and led to several people being hospitalised with hypoglycemia and seizures.[109][110][111] In December 2023, the FDA issued a warning about counterfeit Ozempic in the US.[112]
In the US, compounding pharmacies may prepare compounded versions of a drug on the Food and Drug Administration's (FDA) drug shortages list if the compounded drug meets certain conditions detailed in federal law.[113][114][115] The FDA declared a shortage for Ozempic and Wegovy (but not Rybelsus) starting in August 2022.[116][117]
The US National Association of Boards of Pharmacy claims that there are tens of thousands of online pharmacies operating out of compliance with state and federal regulations or the association's recommendations.[118] Novo Nordisk has taken action against several compounding pharmacies producing bad versions of the drug, with impurities, the wrong amount of active ingredient, or even no active ingredient.[118] Some compounded versions have been found to contain salts of semaglutide, including the sodium and the acetate in an attempt to avoid the patent of the base semaglutide product.[119] These are not evaluated for safety and effectiveness by the FDA and thus are considered not shown to be safe or effective.[120]
A 2014 meta-analysis found that semaglutide may be effective in lowering liver enzymes (transaminitis) and improving certain radiologically observed features of metabolic dysfunction–associated steatotic liver disease.[121] The French national health care insurance system database had previously suggested that one to three years of use of glucagon-like peptide-1 receptor agonists like exenatide, liraglutide, and dulaglutide may be linked with increased occurrence of thyroid cancer. Semaglutide belongs to the same family of medicine. A meta-analysis involving data from 37 randomized controlled trials and 19 real-world studies (46,719 individuals) showed that semaglutide use over 18 months was not associated with increased risk of any cancer, supported by high-quality evidence.[122]
In March 2023, a Novo Nordisk official said, based on a randomized, double-blind study (NCT03548935[123]) funded by the company, that people using semaglutide to lose weight regained two-thirds of their original weight loss one year (52 weeks) after discontinuing use of the drug. After two years (120 weeks), the patients retained roughly one-third of their original weight loss (5.6% of the original 17.3% loss).[124][125]
In June 2025, the European Medicines Agency recommended that the product information for semaglutide medicines be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of 'very rare',[130] while the World Health Organization concluded that the Risk Management Plan for semaglutide should be revised to include non-arteritic anterior ischemic optic neuropathy as a potential risk.[131]
A 2025 observational study reported a modest increased risk of a serious eye condition in people with diabetes taking glucagon-like peptide-1 (GLP-1) receptor agonists.[132] The analysis found that individuals using the medications had a slightly higher incidence of neovascular age-related macular degeneration compared to similar individuals not on the medications.[133] After one year, 0.2% of users of GLP-1 medications developed neovascular age-related macular degeneration versus 0.1% among non-users. The study, which analyzed health data from nearly 140,000 individuals in Canada, controlled for socioeconomic and health-related factors. The average participant age was 66. Since the risk factors for neovascular age-related macular degeneration overlap with those of people prescribed GLP-1 medications, such as diabetes and related conditions, researchers investigated this potential link following reports of other eye-related side effects in people on GLP-1 therapies.
In the STEP-HFpEF trial including people with obesity and heart failure with preserved ejection fraction, weight loss was associated with improvements in heart failure symptoms and functional capacity.[134] An observational study on people with obesity and type 2diabetes and heart failure with preserved ejection fraction, semaglutide had about a 42% lower risk of hospitalization for heart failure and all-cause death combined compared with sitagliptin.[135]
A 2024 systematic review of six studies found that "although reductions in body weight and fat mass were evident, changes in lean mass were minor".[136]
^World Health Organization (2025). The selection and use of essential medicines, 2025: WHO Model List of Essential Medicines, 24th list. Geneva: World Health Organization. doi:10.2471/B09474. hdl:10665/382243. License: CC BY-NC-SA 3.0 IGO.
^Claxton G, Rae M, Damico A, Winger A, Wager E (November 2024). "Health Benefits In 2024: Higher Premiums Persist, Employer Strategies For GLP-1 Coverage And Family-Building Benefits". Health Affairs. 43 (11): 1491–1501. doi:10.1377/hlthaff.2024.01006. PMID39381848.
^Tichy EM, Hoffman JM, Tadrous M, Rim MH, Cuellar S, Clark JS, et al. (July 2024). "National trends in prescription drug expenditures and projections for 2024". American Journal of Health-System Pharmacy. 81 (14): 583–598. doi:10.1093/ajhp/zxae105. PMID38656319.
^Dutta D, Kumar M, Shivaprasad KS, Kumar A, Sharma M (June 2022). "Impact of semaglutide on biochemical and radiologic measures of metabolic-dysfunction associated fatty liver disease across the spectrum of glycaemia: A meta-analysis". Diabetes & Metabolic Syndrome. 16 (6) 102539. doi:10.1016/j.dsx.2022.102539. PMID35709586. S2CID249584781.
^Krüger N, Schneeweiss S, Fuse K, Matseyko S, Sreedhara SK, Hahn G, et al. (31 August 2025). "Semaglutide and Tirzepatide in Patients With Heart Failure With Preserved Ejection Fraction". JAMA. 334 (14): 1255–1266. doi:10.1001/jama.2025.14092. PMID40886075.
^Bikou A, Dermiki-Gkana F, Penteris M, Constantinides TK, Kontogiorgis C (April 2024). "A systematic review of the effect of semaglutide on lean mass: insights from clinical trials". Expert Opinion on Pharmacotherapy. 25 (5): 611–619. doi:10.1080/14656566.2024.2343092. PMID38629387.
^Daniel S, Waggett S, Lyles E, Sagut P, Shamaei Zadeh P, Marcelletti A, et al. (April 2025). "A Retrospective Comparative Analysis of Cutaneous Adverse Reactions in GLP-1 Agonist Therapies". Journal of Drugs in Dermatology. 24 (4): 413–415. doi:10.36849/JDD.8605. PMID40196945.
Clinical trial number NCT03574597 for "Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity (SELECT)" at ClinicalTrials.gov
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From Pubchem
Developed by Eli Lilly and Company, tirzepatide was approved for treatment of diabetes in the U.S. in May 2022,[9][13] in the European Union in September 2022,[11] in Canada in November 2022,[19] and in Australia in December 2022.[2] The U.S. Food and Drug Administration (FDA) considers it a first-in-class medication.[20][21] The FDA approved it for weight loss in November 2023.[16][22] Also in November 2023, the U.K. Medicines and Healthcare products Regulatory Agency revised the indication for tirzepatide (as Mounjaro) to include the treatment for weight management and weight loss.[8][23] In December 2024, the FDA revised the indication for tirzepatide (as Zepbound) to include the treatment of moderate to severe obstructive sleep apnea.[10][17] In 2023, tirzepatide was the 110th-most commonly prescribed medication in the U.S., with more than six million prescriptions.[24][25]
Tirzepatide (as Mounjaro) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.[9][13]
Tirzepatide (as Zepbound) is indicated, alongside a reduced-calorie diet and increased physical activity, for long-term weight reduction in adults with obesity or overweight with at least one weight-related comorbidity.[10][16] Zepbound is also approved for the treatment of moderate-to-severe obstructive sleep apnea in adults with obesity.[10]
Preclinical, phase I, and phase II clinical trials indicated that tirzepatide exhibits adverse effects similar to those of other established GLP-1 receptor agonists, such as dulaglutide (sold as Trulicity) and semaglutide (sold as Wegovy, Ozempic, and Rybelsus). These effects occur largely in the gastrointestinal tract.[26] The most frequently observed are nausea, diarrhea, and vomiting, which increased in incidence with the dosage amount (that is, the higher the dose, the higher the likelihood of side effects). The number of patients who discontinued taking tirzepatide also increased as the dosage increased, with patients taking 15 mg having a 25% discontinuation rate vs 5.1% for 5 mg patients and 11.1% for dulaglutide.[27][clarification needed] To a slightly lesser extent, patients also reported reduced appetite.[26] Other side effects reported were dyspepsia, constipation, abdominal pain, dizziness, and hypoglycemia.[28][29]
A systematic review published in 2024 found that tirzepatide is well tolerated and not associated with pancreatitis.[30]
Tirzepatide has a greater affinity to GIP receptors than to GLP-1 receptors, and this dual agonist behavior has been shown to produce greater reductions of hyperglycemia compared to a selective GLP-1 receptor agonist.[14]Signaling studies reported that tirzepatide mimics the actions of natural GIP at the GIP receptor.[34] At the GLP-1 receptor, though, tirzepatide shows bias toward cAMP (a messenger associated with regulation of glycogen, sugar, and lipid metabolism) generation rather than β-arrestin recruitment. This combination of preference toward GIP receptor and distinct signaling properties at GLP-1 suggest this biased agonism increases insulin secretion.[34] Tirzepatide has been reported to increase levels of adiponectin, an adipokine involved in the regulation of both glucose and lipid metabolism, with a maximum increase of 26% from baseline after 26 weeks, at the 10 mg dosage.[14]
Tirzepatide is an analog of the human GIP hormone with a C20fatty diacid portion attached, used to optimise the uptake and metabolism of the compound.[31] The fatty-diacid section (eicosanedioic acid) is linked via a glutamic acid and two (2-(2-aminoethoxy)ethoxy)acetic acid units to the side chain of the lysine residue. This arrangement allows for a much longer half-life, extending the time between doses, because of its high affinity to albumin.[35]
The synthesis of tirzepatide was first disclosed in patents filed by Eli Lilly and Company in 2016.[36] This uses standard solid phase peptide synthesis, with an allyloxycarbonylprotecting group on the lysine at position 20 of the linear chain of amino acids, allowing a final set of chemical transformations in which the sidechain amine of that lysine is derivatized with the lipid-containing fragment.
Large-scale manufacturing processes have been reported for this compound.[37]
After completing the SURPASS-2 trial (NCT03987919), the company announced in April 2022 that tirzepatide had successfully met its clinical endpoints in obese and overweight participants without diabetes.[39]
In industry-funded preliminary trials, tirzepatide showed minor improvement of reductions (2.01%–2.30% depending on dosage) in glycated hemoglobin tests relative to the injected GLP-1 analog semaglutide (1.86%).[40] A 10 mg dose has also been shown to be effective in reducing insulin resistance, with a reduction of around 8% from baseline, measured using HOMA2-IR (computed with fasting insulin).[14] Fasting levels of insulin-like growth factor (IGF) binding proteins such as IGFBP1 and IGFBP2 increased after tirzepatide treatment, increasing insulin sensitivity.[14]
The FDA approved tirzepatide based on evidence from nine clinical trials of 7,769 participants with type 2 diabetes, of whom 5,415 received tirzepatide.[41] The trials were conducted at 673 sites in 24 countries, including Argentina, Australia, Brazil, Canada, India, Israel, Japan, Mexico, Russian Federation, South Korea, Taiwan, European Union, and the United States (including Puerto Rico).[41] All nine trials were used to assess its safety, and five were used to evaluate its efficacy.[41] The five used in efficacy evaluation included 6,263 adult participants with type 2 diabetes.[41] Four additional trials (NCT03131687, NCT03311724, NCT03861052, and NCT03861039) were included in the safety evaluation, for a total of 7,769 adult participants with type 2 diabetes; therefore, the number of participants representing efficacy findings may differ from the number representing safety findings due to different pools of study participants analyzed for efficacy and safety.[41] Tirzepatide's benefits for the treatment of adult participants with type 2 diabetes were primarily evaluated in five clinical trials.[41] In two of these (NCT03954834 and NCT04039503), participants were randomly assigned to receive either tirzepatide or placebo injection weekly.[41] Neither the patient nor the healthcare provider knew which treatment was being given until after the trials were completed.[41] Treatment was given for 40 weeks.[41] In the other three trials (NCT3987919, NCT03882970, and NCT03730662), participants were randomly assigned to receive either tirzepatide or another antidiabetic medication, and the patient and provider knew which medication was being given.[41] Treatment was given for 40 weeks to 104 weeks.[41] In each trial, HbA1c was measured from the start to the end of the trial and compared between the tirzepatide group and the other groups.[41]
Tirzepatide's efficacy for chronic weight management (weight reduction and maintenance) in combination with a reduced-calorie diet and increased physical activity was established in two randomized, double-blind, placebo-controlled trials of adults with obesity or overweight with at least one weight-related condition.[16] These studies measured weight reduction after 72 weeks in 2,519 participants who received either 5 mg, 10 mg, or 15 mg of tirzepatide once weekly and 958 participants who received weekly placebo injections.[16] In both trials, after 72 weeks of treatment, participants who received tirzepatide at all three dose levels experienced a statistically significant reduction in body weight compared to those who received placebo, and greater proportions of participants who received tirzepatide achieved at least 5% weight reduction compared to placebo.[16]
In August 2024, the SURMOUNT-1 three-year study (176-week treatment period) found that tirzepatide reduced the risk of developing type 2 diabetes by 94% in adults with pre-diabetes and obesity or overweight.[42]
A 2021 meta-analysis found that over one year of clinical use, tirzepatide was superior to dulaglutide, semaglutide, insulin degludec, and insulin glargine in improving blood sugar and obesity.[43]
In a phase III double-blind, randomized, controlled trial supported by Eli Lilly, nondiabetic adults with a body mass index of 30 or more, or 27 or more and at least one weight-related complication, excluding diabetes, were randomized to receive once-weekly, subcutaneous tirzepatide (5 mg, 10 mg, or 15 mg) or placebo. The mean percentage change in weight at week 72 was −15.0% (95% confidence interval [CI], −15.9 to −14.2) with 5-mg weekly doses of tirzepatide, −19.5% (95% CI, −20.4 to −18.5) with 10-mg doses, and −20.9% (95% CI, −21.8 to −19.9) with 15-mg doses. Weight change in the placebo group was −3.1% (95% CI, −4.3 to −1.9).[44][45][46]
In July 2022, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending granting a marketing authorization for the medicinal product Mounjaro, intended for the treatment of type2 diabetes.[47] Tirzepatide was approved for medical use in the European Union in September 2022.[11][48]
In December 2024, the FDA approved tirzepatide (Zepbound) as the first medication to be used in the treatment of moderate to severe obstructive sleep apnea.[17][49][50] The FDA granted the application for tirzepatide (Zepbound) fast track, priority review, and breakthrough therapy designations for the treatment of moderate to severe obstructive sleep apnea.[17] The FDA granted the approval of Zepbound to Eli Lilly.[17]
In the U.S., some compounding pharmacies prepare compounded versions of a drug on the FDA's drug shortages list if the compounded drug meets certain conditions detailed in federal law.[51][52][53] The FDA declared a shortage of tirzepatide in December 2022.[54] It declared the shortage over in October 2024, but enforcement was delayed until the end of 2024, after a lawsuit by compounding pharmacies challenged the declaration.[55][56]
The U.S. National Association of Boards of Pharmacy says there are tens of thousands of online pharmacies operating out of compliance with state and federal regulations or the association's recommendations.[57] The FDA has not evaluated these for safety and effectiveness and they are thus considered not to have been shown to be safe or effective.[58]
In a phase III trial, tirzepatide demonstrated clinically significant benefits among participants with obesity and heart failure with preserved ejection fraction.[59][60] Over two years of follow-up, tirzepatide decreased participants' risk of major cardiovascular (CV) complications—a combined endpoint including urgent heart failure visits, hospitalizations, more frequent diuretic treatment, and CV mortality—by 38% compared to a placebo.[61] An observational study on patients with obesity and type 2 diabetes and heart failure with preserved ejection fraction reported that tirzepatide had a lower risk of hospitalization for heart failure and all-cause death combined than sitagliptin.[62][63] In a 72-week, phase IIIb open-label head-to-head trial of adults with obesity without diabetes, tirzepatide at the maximum tolerated dose produced greater mean weight loss than semaglutide and larger reductions in waist circumference, while gastrointestinal adverse events were the most common with both drugs.[64]
After stopping treatment with tirzepatide for obesity, people on average regain more than half (53%) of the weight they lost during treatment within a year.[65][66]
^ abc"Mounjaro EPAR". European Medicines Agency (EMA). 18 July 2022. Archived from the original on 12 December 2022. Retrieved 2 January 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^World Health Organization (2019). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 81". WHO Drug Information. 33 (1). hdl:10665/330896.
^ abUS patent 9474780, Bokvist BK, Coskun T, Cummins RC, Alsina-Fernandez J, "GIP and GLP-1 co-agonist compounds", issued 25 October 2016, assigned to Eli Lilly and Co
^"Mounjaro: Pending EC decision". European Medicines Agency. 22 July 2022. Archived from the original on 28 July 2022. Retrieved 30 July 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^Aronne LJ, Horn DB, le Roux CW, Ho W, Falcon BL, Gomez Valderas E, et al. (July 2025). "Tirzepatide as Compared with Semaglutide for the Treatment of Obesity". The New England Journal of Medicine. 393 (1): 26–36. doi:10.1056/NEJMoa2416394. PMID40353578.
Do I need a prescription to get semaglutide for weight loss?
Yes. In the United States, FDA-approved semaglutide products—such as Wegovy and Ozempic—require a prescription from a licensed clinician. Safe prescribing includes a full medical evaluation, a review of current medications, and often baseline lab work. Any service offering semaglutide without a prescription is unsafe and may be selling counterfeit or unregulated products.
Can I start semaglutide through telehealth instead of an in-person visit?
In many cases, yes. California allows clinicians to prescribe semaglutide through a legitimate telemedicine visit as long as it includes a real-time video consultation and a full review of medical history. Most patients complete labs locally and begin treatment with clear dosing instructions and follow-up support. Some choose an in-person visit for their first injection, but it’s not required for everyone.
What should I watch for to make sure a semaglutide program is safe?
A safe program includes screening for contraindications, baseline lab testing, a gradual dose escalation schedule, and consistent follow-ups to monitor side effects and progress. Red flags include no medical visit, no labs, unclear medication sources, or aggressive dose increases. Programs that offer patient support, side-effect management, and transparent medication sourcing help protect your health and improve weight-loss outcomes.
