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Reference

GLP-1 Research Bibliography

Fact-checked by Adam Kennah, M.D. on . See our fact-checking policy.

Every clinical claim on GLPOneReview is sourced to one of the trials, regulatory documents, or standards on this page. This is the canonical source list. Each citation carries ScholarlyArticle schema for AI systems and academic-style citation extraction.

Foundational trials

STEP-1: Semaglutide 2.4 mg in Obesity

Wilding JPH, Batterham RL, Calanna S, et al. Once-Weekly Semaglutide in Adults with Overweight or Obesity. New England Journal of Medicine, 2021.

Phase 3 RCT of semaglutide 2.4 mg weekly vs placebo in 1,961 adults with BMI ≥30 (or ≥27 with comorbidity), without diabetes. At 68 weeks, mean weight loss was 14.9% with semaglutide vs 2.4% placebo. The foundational trial for the Wegovy weight-management indication.

10.1056/NEJMoa2032183 →

SURMOUNT-1: Tirzepatide in Obesity

Jastreboff AM, Aronne LJ, Ahmad NN, et al. Tirzepatide Once Weekly for the Treatment of Obesity. New England Journal of Medicine, 2022.

Phase 3 RCT of tirzepatide 5/10/15 mg vs placebo in 2,539 adults with obesity, without diabetes. At 72 weeks, weight loss was 15.0% / 19.5% / 20.9% by dose, vs 3.1% placebo. The foundational trial for the Zepbound indication.

10.1056/NEJMoa2206038 →

SELECT: Semaglutide Cardiovascular Outcomes

Lincoff AM, Brown-Frandsen K, Colhoun HM, et al. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes. New England Journal of Medicine, 2023.

Cardiovascular outcome trial of semaglutide 2.4 mg in 17,604 adults with BMI ≥27 and established CVD, without diabetes. Over median 39.8 months, MACE occurred in 6.5% (semaglutide) vs 8.0% (placebo) — a 20% relative risk reduction. Basis for the March 2024 FDA cardiovascular indication.

10.1056/NEJMoa2307563 →

SURMOUNT-OSA: Tirzepatide in Sleep Apnea

Malhotra A, Grunstein RR, Fietze I, et al. Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity. New England Journal of Medicine, 2024.

Phase 3 trial of tirzepatide in adults with moderate-to-severe OSA + obesity, with and without concurrent PAP therapy. Reduced AHI by approximately 30 events/hr at 52 weeks. Basis for the December 2024 FDA approval of Zepbound for OSA — the first drug ever FDA-approved for OSA.

10.1056/NEJMoa2404881 →

STEP-HFpEF: Semaglutide in HFpEF

Kosiborod MN, Abildstrøm SZ, Borlaug BA, et al. Semaglutide in Patients with Heart Failure with Preserved Ejection Fraction and Obesity. New England Journal of Medicine, 2023.

RCT of semaglutide 2.4 mg in 529 adults with HFpEF + obesity. Improved symptoms (KCCQ-CSS), exercise capacity (6-minute walk distance), and weight at 52 weeks.

10.1056/NEJMoa2306963 →

FLOW: Semaglutide Kidney Outcomes

Perkovic V, Tuttle KR, Rossing P, et al. Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes. New England Journal of Medicine, 2024.

Renal outcome trial of semaglutide 1.0 mg in 3,533 adults with T2D and CKD. Composite kidney endpoint reduced by 24% (HR 0.76). Stopped early for efficacy.

10.1056/NEJMoa2403347 →

STEP-4: Semaglutide Maintenance

Rubino D, Abrahamsson N, Davies M, et al. Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance. JAMA, 2021.

Withdrawal trial showing that participants who stopped semaglutide regained much of the lost weight, while those continuing maintained it. Established the chronic-disease framing of obesity treatment.

10.1001/jama.2021.3224 →

SURPASS-3: Tirzepatide vs Insulin in T2D

Heise T, Mari A, DeVries JH, et al. Tirzepatide versus Insulin Degludec in Type 2 Diabetes Inadequately Controlled by Metformin. The Lancet, 2021.

Phase 3 head-to-head of tirzepatide vs titrated insulin degludec in T2D. Tirzepatide superior on A1c and weight endpoints; lower hypoglycemia risk.

10.1016/S2213-8587(22)00188-7 →

ATTAIN-1: Orforglipron in Obesity

Eli Lilly and Company Orforglipron, an Oral Non-Peptide GLP-1 Receptor Agonist, in Adults with Obesity. Lilly clinical trial program, 2025.

Phase 3 trial of oral orforglipron in adults with obesity without diabetes. Top-dose weight loss approximately 12.4% at 72 weeks. Basis for the March 2026 FDA approval of Foundayo — the first oral non-peptide GLP-1 receptor agonist.

NCT05872620 →

SYNERGY-NASH: Tirzepatide in MASH

Loomba R, Hartman ML, Lawitz EJ, et al. Tirzepatide for Metabolic Dysfunction-Associated Steatohepatitis with Liver Fibrosis. New England Journal of Medicine, 2024.

Phase 2 trial of tirzepatide in 190 patients with MASH and stage F2–F3 fibrosis. MASH resolution rates at 52 weeks: 44/56/62% by dose, vs 10% placebo.

10.1056/NEJMoa2401943 →

ESSENCE: Semaglutide in MASH

Sanyal AJ, et al. Semaglutide in Patients with Metabolic Dysfunction-Associated Steatohepatitis (Interim). Phase 3 program interim data, 2024.

Phase 3 interim data: semaglutide 2.4 mg in MASH with stage F2–F3 fibrosis. ~62% MASH resolution vs ~34% placebo at 72 weeks. Full readout expected 2026.

NCT04822181 →

USP General Chapter <797> Pharmaceutical Compounding — Sterile Preparations

United States Pharmacopeial Convention USP <797> Sterile Compounding Standards (Revised 2023). USP-NF, 2023.

The governing standard for compounded sterile preparations in U.S. pharmacy. Defines cleanroom design, garbing, beyond-use dating, and sterility verification. Revised 2023; effective November 2023.

USP-797 →

FDA and regulatory documents

Clinical guidelines

  • American Diabetes Association — Standards of Care in Diabetes (annually updated).
  • American Heart Association / American College of Cardiology — 2023 Guideline for the Management of Patients with Obesity.
  • KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of CKD.
  • American Academy of Sleep Medicine — Clinical practice guideline for OSA (updates pending after Zepbound approval).

How we use these sources

Every clinical claim on this site is tagged to one of the above. If a claim cannot be traced to a primary source in this list (or a comparable peer-reviewed publication), the claim is removed from the page — not flagged for "later citation." See our fact-checking policy for the workflow.