Study S001712

Efficacy and Safety of Tirzepatide Once Weekly in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-2)

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT04657003
Acronym: SURMOUNT-2
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 938
Start: 2021-03-29
Primary completion: 2023-03-16
Lead sponsor: Eli Lilly and Company
Conditions: Type 2 Diabetes; Overweight; Obesity
Interventions: DRUG:Tirzepatide; OTHER:Placebo
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:I8F-MC-GPHL

Registered primary outcomes

Percent Change From Baseline in Body Weight [Baseline, Week 72]
Percentage of Participants Who Achieve ≥5% Body Weight Reduction From Baseline [Week 72]

Linked records (9)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0007749	Psychiatric Safety of Tirzepatide in People With Obesity and No Known Major Psychopathology: A Post Hoc Analysis of SURMOUNT. Wadden TA, Obesity (Silver Spring, Md.)	2026	Other trial	PMID 41537305 DOI	cites ClinicalTrials.gov:NCT04657003; registry reference DERIVED:41537305
R0013565	Tirzepatide Efficacy and Tolerability According to Early Weight Response: A Post Hoc Analysis of the SURMOUNT-1 and SURMOUNT-2 Trials. Kokkinos A, Diabetes, obesity & metabolism	2026	Randomized trial	PMID 42348366 DOI	cites ClinicalTrials.gov:NCT04657003; registry reference DERIVED:42348366
R0014849	Nutritional status with tirzepatide in obesity: A post hoc analysis of the SURMOUNT-1-4 randomized clinical trials. Almandoz JP, Obesity pillars	2026	Randomized trial	PMID 41640675 DOI	cites ClinicalTrials.gov:NCT04657003
R0016891	Kidney Parameters with Tirzepatide in Obesity with or without Type 2 Diabetes. Heerspink HJL, Journal of the American Society of Nephrology : JASN	2025	Randomized trial	PMID 40512543 DOI	cites ClinicalTrials.gov:NCT04657003; registry reference DERIVED:40512543
R0016962	Tirzepatide Was Associated with Improved Health-Related Quality of Life in Adults with Obesity or Overweight and Type 2 Diabetes: Results from the Phase 3 SURMOUNT-2 Trial. Hunter Gibble T, Diabetes therapy : research, treatment and education of diabetes and related disorders	2025	Randomized trial	PMID 40120035 DOI	cites ClinicalTrials.gov:NCT04657003; registry reference DERIVED:40120035
R0050171	1700-P: Weight Reduction Is Associated with Improved Quality of Life in Participants with Obesity or Overweight and Type 2 Diabetes—Results from Phase 3 SURMOUNT-2 Trial Theresa M. Hunter, Diabetes	2024	Randomized trial	DOI	cites ClinicalTrials.gov:NCT04657003
R0008073	Tirzepatide for the treatment of obesity: Rationale and design of the SURMOUNT clinical development program. le Roux CW, Obesity (Silver Spring, Md.)	2023	Protocol	PMID 36478180 DOI	cites ClinicalTrials.gov:NCT04657003
R0008662	Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Garvey WT, Lancet (London, England)	2023	Randomized trial	PMID 37385275 DOI	cites ClinicalTrials.gov:NCT04657003; registry reference DERIVED:37385275
R0047034	Tirzepatide maintained significant weight loss when treatment was continued in a follow‐up study ISKANDAR RAUF IDRIS, Diabetes Obesity and Metabolism Now	2023	Randomized trial	DOI	cites ClinicalTrials.gov:NCT04657003