At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,539 enrolled
Drug / intervention
Tirzepatide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety of Tirzepatide Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight- Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-1)
In Brief
A Phase 3 clinical trial evaluating Tirzepatide and Placebo for Overweight and Obesity. Completed, enrolled 2,539 participants across 118 sites in 10 countries.
Detailed Summary
This is a study of tirzepatide in participants with overweight and obesity. The main purpose is to learn more about how tirzepatide affects body weight. The study has two phases: A main phase and an extension phase. The main phase of the study will last 72 weeks. Participants with prediabetes will continue in the extension for another 2 years.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOverweight, Obesity
CountriesArgentina, Brazil, China, India, Japan, Mexico, Puerto Rico, Russia, Taiwan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedDec 2019
Enrollment StartDec 2019
Primary CompletionApr 2022
Study CompletionJul 2024
TodayJul 2026
First PostedDec 3, 2019
Enrollment StartDec 4, 2019
Primary CompletionApr 1, 2022
Study CompletionJul 6, 2024
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 6.6 years ago
Interventions
Tirzepatidedrug
Administered SC
Placebodrug
Administered SC