Reference
Fact-checked by Dr. Adam Kennah, MD on . See our fact-checking policy.
The peer-reviewed clinical trials, regulatory guidance documents, and pharmacy standards underlying every clinical claim on GLP Agonists. 12 entries; every page on this site that makes a clinical claim links back to a primary source on this bibliography.
Pivotal Phase 3 trial of semaglutide 2.4 mg weekly in adults without diabetes. Mean weight loss of 14.9% over 68 weeks vs. 2.4% placebo. Established the efficacy basis for Wegovy's FDA approval.
Pivotal Phase 3 trial of tirzepatide in adults with obesity. Mean weight loss of 20.9% at 15 mg dose over 72 weeks vs. 3.1% placebo. Established efficacy basis for Zepbound.
Cardiovascular outcomes trial in adults with overweight/obesity and pre-existing CV disease but without diabetes. Semaglutide 2.4 mg reduced major adverse cardiovascular events by 20% vs. placebo over 39.8 months.
Phase 3 trial demonstrating that tirzepatide reduces apnea-hypopnea index (AHI) by 25-29 events/hour vs. 5-6 events/hour with placebo in adults with obesity and moderate-to-severe OSA. Basis for Zepbound's December 2024 OSA indication.
Semaglutide 2.4 mg improved symptoms and physical function in patients with heart failure with preserved ejection fraction and obesity.
Semaglutide reduced the risk of major kidney disease events by 24% in patients with type 2 diabetes and chronic kidney disease.
Two-year extension showing weight loss sustained at 15.2% with continued treatment. Demonstrated weight regain after discontinuation.
Demonstrated that continued semaglutide treatment maintains weight loss; switching to placebo results in significant regain.
Tirzepatide reduced HbA1c by ~2% and produced weight loss across all dose arms (5, 10, 15 mg) vs. weight gain with insulin degludec.
Phase 3 trial of oral non-peptide GLP-1 RA orforglipron. Demonstrated weight loss of ~13-15% over 72 weeks, approaching injectable GLP-1 efficacy without fasting requirements. Basis for Foundayo 2026 FDA approval.
The reference standard governing sterile compounding in U.S. pharmacies. Defines facility, personnel, and process requirements for low-, medium-, and high-risk sterile preparations.
FDA guidance establishing enforcement-discretion end dates for compounded GLP-1: tirzepatide 503A Feb 18 2025 / 503B Mar 19 2025; semaglutide 503A Apr 22 2025 / 503B May 22 2025. Continued compounding now requires documented medical necessity.
Three classes of source make it into this bibliography:
We do not cite preprints, conference abstracts, manufacturer-sponsored white papers, or news-aggregator summaries as primary sources.