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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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
Expert commentary on why this trial matters and what to watch for.
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