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NCT04184622PHASE3COMPLETED

A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight

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)

Sponsor: Eli Lilly and Company

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type
INTERVENTIONAL
Conditions
Overweight, Obesity
Interventions
Tirzepatide, Placebo
Enrollment
2,539 participants
Primary completion
Apr 2022
Study completion
Jul 2024
First posted
Dec 2019
Last updated
Jul 2025

Primary Endpoints (CT.gov)

Percent Change From Baseline in Body Weight (Primary Treatment Period)

Time frame: Baseline, Week 72

Percentage of Participants Who Achieve ≥5% Body Weight Reduction (Primary Treatment Period)

Time frame: Week 72

Secondary Endpoints

Change From Baseline in Body Weight (Pooled Doses of Tirzepatide 10 mg and 15 mg) - Primary Treatment Period

Percentage of Participants Who Achieve ≥10% Body Weight Reduction (Primary Treatment Period)

Percentage of Participants Who Achieve ≥15% Body Weight Reduction (Primary Treatment Period)

Eligibility Criteria

Inclusion Criteria: * Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≥27 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease * History of at least one unsuccessful dietary effort to lose body weight Exclusion Criteria: * Diabetes mellitus * Change in body weight greater than 5 kg within 3 months prior to starting study * Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity * History of pancreatitis * Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) * History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years * Any lifetime history of a suicide attempt

✦ Analyst Commentary

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Source

Open on ClinicalTrials.gov