Study S001216

Efficacy and Safety of Once-Weekly Tirzepatide in Participants With Obesity Disease: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-J)

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

Registration

Registration: NCT04844918
Acronym: SURMOUNT-J
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 267
Start: 2021-05-10
Primary completion: 2023-06-24
Lead sponsor: Eli Lilly and Company
Conditions: Obesity
Interventions: DRUG:Tirzepatide; OTHER:Placebo
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:I8F-JE-GPHZ

Registered primary outcomes

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

Linked records (4)

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
R0013407	Effect of Tirzepatide on Health-Related Quality of Life in Japanese Patients With Obesity Disease: Patient-Reported Outcomes From the SURMOUNT-J Study. Masuzaki H, Diabetes, obesity & metabolism	2026	Randomized trial	PMID 42108080 DOI	cites ClinicalTrials.gov:NCT04844918; registry reference DERIVED:42108080
R0013714	Post hoc analysis of SURMOUNT-J: tirzepatide versus placebo and predicted 10-year cardiovascular disease risk in Japanese adults with obesity disease. Node K, Current medical research and opinion	2026	Nonrandomized study	PMID 42287159 DOI	cites ClinicalTrials.gov:NCT04844918; registry reference DERIVED:42287159
R0014642	Association of baseline characteristics with clinical outcomes of tirzepatide treatment in Japanese patients with obesity disease: A subgroup analysis of the SURMOUNT-J trial. Yokote K, Diabetes, obesity & metabolism	2026	Randomized trial	PMID 41290555 DOI	cites ClinicalTrials.gov:NCT04844918; registry reference DERIVED:41290555
R0016732	Efficacy and safety of once-weekly tirzepatide in Japanese patients with obesity disease (SURMOUNT-J): a multicentre, randomised, double-blind, placebo-controlled phase 3 trial. Kadowaki T, The lancet. Diabetes & endocrinology	2025	Randomized trial	PMID 40031941 DOI	cites ClinicalTrials.gov:NCT04844918; registry reference DERIVED:40031941