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GLP-1 receptor agonist (acylated GLP-1 analogue)

Semaglutide — evidence

What has been published, classified by the kind of document it is. This is not a protocol, not a score, and not a recommendation for use.

Evidence overview

4 records in this file

  • CLINICAL TRIAL2
  • REGULATORY2

Research areas. Approved-drug Phase 3; Unapproved GLP-1 products; United States approval.

Publication span. 2016–2026.

What we know

  • Three FDA-approved products exist (Ozempic, Rybelsus, Wegovy), with large Phase 3 programmes (including STEP 1 and SUSTAIN-6) published in NEJM.
  • That evidence base is about the approved, labelled products under medical supervision — not about unapproved GLP-1 products.
  • FDA has issued separate communications on unapproved GLP-1 products marketed for weight loss.

Editorial reading of the records below, labelled as Therapept analysis. How records are built

What remains uncertain

  • Nothing in this file characterises unapproved look-alike products. Their composition is a documentation problem for a specific lot.

Regulatory notes

FDA-approved drug substance

  • Approved prescription drug substance. Ozempic approved 5 December 2017; Rybelsus 20 September 2019; Wegovy 4 June 2021.
  • Not placed in FDA's Category 2 of bulk substances that may present significant safety risks.
  • FDA proposed in April 2026 to exclude semaglutide from the 503B bulks list, stating it did not identify sufficient evidence for inclusion.
  • FDA has issued separate communications concerning unapproved GLP-1 products marketed for weight loss.

Regulatory status describes how a substance is classified. It is not a safety assessment of any particular material.

Studies and documents

  1. REGULATORY2026Regulatory communication

    FDA's concerns about unapproved GLP-1 drugs used for weight loss

    U.S. Food and Drug AdministrationFDA drug alerts and statements

    Objective
    To record FDA's published position on unapproved GLP-1 products.
    Endpoint investigated
    Regulatory status of unapproved GLP-1 products

    FDA has issued communications concerning unapproved GLP-1 products marketed for weight loss, separate from the approved NDA products. The communication is about products that are not the labelled drugs.

    Limitations. A safety communication is not a trial. It does not characterise any named research vendor.

    FDA — Concerns about unapproved GLP-1 drugs used for weight lossReviewed 12 September 2026

  2. REGULATORY2021Approved-drug labelling

    Drugs@FDA — Ozempic (NDA 209637), Rybelsus (NDA 213051), Wegovy (NDA 215256)

    U.S. Food and Drug AdministrationDrugs@FDA

    Objective
    To record that three approved United States products exist, with application numbers.
    Endpoint investigated
    Marketing authorisation, not a new experimental endpoint

    Ozempic approved 5 December 2017; Rybelsus 20 September 2019; Wegovy 4 June 2021. Labelling is the authoritative statement of approved indications and is not reproduced here as medical advice.

    Limitations. Label indications are product-specific. They do not describe research-chemical catalogues.

    Drugs@FDA — approved drug productsReviewed 12 September 2026

  3. CLINICAL TRIAL2021Randomised, double-blind, placebo-controlled trial

    Once-weekly semaglutide in adults with overweight or obesity (STEP 1)

    Wilding JPH, Batterham RL, Calanna S, et al.New England Journal of Medicine

    Population
    Adults with overweight or obesity, without diabetes, in a registered Phase 3 programme
    Sample
    n = 1,961
    Objective
    To test once-weekly subcutaneous semaglutide 2.4 mg versus placebo for body-weight change in the STEP 1 trial.
    Endpoint investigated
    Body-weight change and related endpoints in STEP 1

    Phase 3 randomised trial of the approved 2.4 mg weekly dose versus placebo in adults with overweight or obesity. Primary results were published in NEJM. This is labelled, approved-drug evidence — not research-chemical catalogue evidence.

    Limitations. Trial population, dose, product and supervision are those of the approved drug programme. Findings do not transfer to unapproved look-alike products.

    DOI 10.1056/NEJMoa2032183Wilding et al., N Engl J Med (2021) — STEP 1Reviewed 12 September 2026

  4. CLINICAL TRIAL2016Randomised, double-blind, placebo-controlled cardiovascular trial

    Semaglutide and cardiovascular outcomes in patients with type 2 diabetes (SUSTAIN-6)

    Marso SP, Bain SC, Consoli A, et al.New England Journal of Medicine

    Population
    Adults with type 2 diabetes at high cardiovascular risk
    Sample
    n = 3,297
    Objective
    To assess cardiovascular outcomes with once-weekly semaglutide in type 2 diabetes.
    Endpoint investigated
    Major adverse cardiovascular events in SUSTAIN-6

    Cardiovascular outcomes trial of approved semaglutide in type 2 diabetes, published in NEJM. Part of the labelled evidence base for the approved products.

    Limitations. Diabetes / high-CV-risk population; approved product. Not a statement about unapproved GLP-1 products.

    DOI 10.1056/NEJMoa1607141Marso et al., N Engl J Med (2016) — SUSTAIN-6Reviewed 12 September 2026

Last reviewed 3 September 2026 · Compiled by Therapept Editorial · How these records are built