Semaglutide is a GLP-1 receptor agonist sold as Ozempic, Wegovy, and Rybelsus for specific FDA-approved indications. Randomized trials support diabetes and chronic weight-management uses. Off-label, compounded, and broader behavioral claims require separate evidence and regulatory review.
GLP-1 receptor agonist
Semaglutide
Semaglutide is a GLP-1 receptor agonist sold as Ozempic, Wegovy, and Rybelsus for specific FDA-approved indications. Randomized trials support diabetes and chronic weight-management uses. Off-label, compounded, and broader behavioral claims require separate evidence and regulatory review.
Evidence review
Last reviewed Jul 1, 2026
Next review Jul 29, 2026
Evidence snapshot
FDA-approved as Ozempic for Type 2 diabetes (2017), Wegovy for chronic weight management (2021), and Rybelsus as an oral formulation for Type 2 diabetes (2019).
STEP 1 Phase 3 trial showed mean weight loss of 14.9% at 68 weeks, published in NEJM (2021).
SELECT cardiovascular outcomes trial demonstrated reduced major adverse cardiovascular events in non-diabetic patients with obesity, published in NEJM (2023).
Extensive media coverage and compounded-product discussion are public-attention signals, not evidence of additional approved indications.
SUSTAIN-6 trial established cardiovascular safety in Type 2 diabetes patients.
Research record
What the evidence record says
- Evidence grade
- Not Graded
- Regulatory status
- Semaglutide regulatory status has not been fully reviewed by Peptide Report editorial team. See company profiles and regulatory watch for current status.
Evidence records
Studies, registries, reviews, and regulatory records
Evidence review pending
- Detailed evidence review for Semaglutide is pending editorial assessment. Current summary reflects available public records.
Records: Semaglutide 2.4 mg Once a Week in Adults with Overweight or Obesity (STEP 1), Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes (SELECT), Semaglutide and Cardiovascular Outcomes in Type 2 Diabetes (SUSTAIN-6)
Evidence timeline
What changed, and when
Peptide Report last reviewed Semaglutide on 2026-07-01.
Records: Semaglutide 2.4 mg Once a Week in Adults with Overweight or Obesity (STEP 1)
Direct answers
Frequently asked questions
What is Semaglutide?
Semaglutide is a glp-1 receptor agonist tracked by Peptide Report. See the full profile for current editorial assessment.
Open research questions
What is still unknown
- What is the complete human evidence base for Semaglutide?
- What are the long-term safety considerations for Semaglutide?
Tracked claims
Semaglutide showed weight loss of approximately 15% in the STEP 1 Phase 3 clinical trial.
Evidence level: Peer reviewed
Sources: Semaglutide 2.4 mg Once a Week in Adults with Overweight or Obesity (STEP 1), STEP 1: Semaglutide for Obesity: ClinicalTrials.gov
How to read this: Cite the NEJM STEP 1 publication. Results are specific to the trial population and dosing protocol.
The SELECT trial demonstrated cardiovascular benefit for semaglutide in non-diabetic patients with obesity.
Evidence level: Peer reviewed
Sources: Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes (SELECT), SELECT: Semaglutide Cardiovascular Outcomes: ClinicalTrials.gov
How to read this: SELECT was a landmark CV outcomes trial. Track any subsequent label expansions based on this data.
Semaglutide is FDA-approved for Type 2 diabetes (Ozempic, Rybelsus) and chronic weight management (Wegovy).
Evidence level: Primary regulatory
Sources: FDA Approves Ozempic (Semaglutide) for Type 2 Diabetes, FDA Approves Wegovy (Semaglutide) for Chronic Weight Management
How to read this: Confirm approval status against FDA records on each review cycle. Track compounded semaglutide regulatory actions.
Online discussions about semaglutide span weight loss, appetite suppression, and emerging behavioral effects.
Evidence level: Community discussion
Sources: Ozempic is a game-changer. Here's how it works., What Ozempic & Weight Loss Drugs Really Do to the Body, Doctors explain how Wegovy and Ozempic work | 60 Minutes
How to read this: Track media claims that may exceed clinical evidence. Separate approved indications from speculative behavioral and addiction claims.
Linked public records
Regulatory actions involving Semaglutide
Ready Med: FDA Warning Letter 730317
Agency warning · Open public record
FDA stated that Ready Med's website claims about compounded semaglutide and tirzepatide could imply equivalence with approved drugs and could obscure which entity compounded the products.
Compounds: Semaglutide, Tirzepatide
D&H Medical Services: FDA Warning Letter 728238
Agency warning · Open public record
FDA issued a warning letter concerning website presentation and marketing claims for compounded semaglutide and tirzepatide products. The linked source is the agency's complete public record.
Compounds: Semaglutide, Tirzepatide
FDA proposes excluding semaglutide, tirzepatide, and liraglutide from the 503B Bulks List
Proposal · Proposal; comment period closed
FDA proposed excluding three GLP-1 active ingredients from the 503B Bulks List after preliminarily finding no clinical need for outsourcing facilities to compound them from bulk substances. The proposal is not a final determination.
Compounds: Semaglutide, Tirzepatide
FDA announces warning letters to 30 telehealth companies over compounded GLP-1 marketing
Agency warnings · Agency initiative announced
FDA announced 30 warning letters addressing claims that could imply compounded GLP-1 products were the same as FDA-approved products or obscure the source of the compounded product.
Compounds: Semaglutide, Tirzepatide
FDA announces intent to act against mass-marketed non-approved compounded GLP-1 drugs
Intent announced · Policy statement
FDA announced intended enforcement steps involving GLP-1 active pharmaceutical ingredients used in mass-marketed non-approved compounded drugs and misleading direct-to-consumer promotion. The statement named Hims & Hers among the companies in scope but was not itself a final adjudication against that company.
Companies: Hims & Hers
Compounds: Semaglutide, Tirzepatide
FDA alerts on dosing errors involving compounded injectable semaglutide
Safety communication · Active safety communication
FDA reported adverse events, including some requiring hospitalization, associated with dosing errors involving compounded injectable semaglutide and described risks tied to varying concentrations, vial-and-syringe measurement, and unit conversion.
Compounds: Semaglutide
Free report
Get the source-quality checklist
Use the same checklist Peptide Report uses to separate Semaglutide claims, source records, supplier documentation, and media signals.
V1 collects email, role, and topic interest only. No medication, health-condition, dosing, or current-use data is collected in this form.
Formspree processes this submission for Peptide Report. Privacy notice.
Sources on this page
Each source record is linked to the claim or evidence note it supports.
Semaglutide 2.4 mg Once a Week in Adults with Overweight or Obesity (STEP 1)
Phase 3 trial showing semaglutide 2.4 mg weekly achieved mean weight loss of 14.9% at 68 weeks.
6 linked pagesOpen original ·
nejm-semaglutide-step1-2021Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes (SELECT)
Cardiovascular outcomes trial showing semaglutide reduced major adverse CV events in non-diabetic patients with obesity.
5 linked pagesOpen original ·
nejm-semaglutide-select-2023Semaglutide and Cardiovascular Outcomes in Type 2 Diabetes (SUSTAIN-6)
Pre-specified CV outcomes trial establishing cardiovascular safety of semaglutide in Type 2 diabetes.
3 linked pagesOpen original ·
nejm-semaglutide-sustain6-2016STEP 1: Semaglutide for Obesity: ClinicalTrials.gov
ClinicalTrials.gov registry for STEP 1, the pivotal semaglutide obesity trial.
4 linked pagesOpen original ·
clinicaltrials-gov-step1SELECT: Semaglutide Cardiovascular Outcomes: ClinicalTrials.gov
ClinicalTrials.gov registry for the SELECT cardiovascular outcomes trial of semaglutide.
4 linked pagesOpen original ·
clinicaltrials-gov-selectSUSTAIN-6: Semaglutide CV Outcomes in T2D: ClinicalTrials.gov
ClinicalTrials.gov registry for SUSTAIN-6, establishing CV safety of semaglutide in Type 2 diabetes.
3 linked pagesOpen original ·
clinicaltrials-gov-sustain6FDA Approves Ozempic (Semaglutide) for Type 2 Diabetes
FDA approval of Ozempic (semaglutide) injection for Type 2 diabetes, NDA 209637.
8 linked pagesOpen original ·
fda-ozempic-approval-2017FDA Approves Wegovy (Semaglutide) for Chronic Weight Management
FDA approval of Wegovy (semaglutide 2.4 mg) injection for chronic weight management, NDA 215256.
9 linked pagesOpen original ·
fda-wegovy-approval-2021Ozempic is a game-changer. Here's how it works.
High-view (3.5M+) Vox explainer on Ozempic/semaglutide. Tracked as major media signal for public claims.
2 linked pagesOpen original ·
youtube-vox-ozempic-2023What Ozempic & Weight Loss Drugs Really Do to the Body
High-view (2.9M+) anatomy-focused explainer. Tracked for physiological claims about GLP-1 drugs.
2 linked pagesOpen original ·
youtube-anatomy-lab-ozempic-2025Doctors explain how Wegovy and Ozempic work | 60 Minutes
Mainstream media coverage of Wegovy/Ozempic. Tracked for regulatory and clinical claims in public discourse.
3 linked pagesOpen original ·
youtube-60minutes-wegovy-2023Related compounds
Retatrutide
Retatrutide has produced large weight reductions in randomized Phase 2 and Phase 3 trials, but it remains unapproved. Lo...
Regulatory watchTirzepatide
Tirzepatide is a dual GIP and GLP-1 receptor agonist sold as Mounjaro and Zepbound for specific FDA-approved indications...
Evidence reviewStay informed
Track Semaglutide with Peptide Report
Get FDA Watch Alerts for Semaglutide
Subscribe for regulatory updates, new trial data, and source-backed claim revisions.
See claims about Semaglutide fact-checked
3 video claims checked in our video claim scanner.
Compare Semaglutide with similar compounds
2 comparison pages available:
Semaglutide vs Tirzepatide for Weight Loss · Tirzepatide vs Semaglutide