NCT07481747 Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo in Participants Who Are Either Obese or Overweight With Weight-Related Comorbidities (SURMOUNT-1)

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.

This trial targets 2,539 participants in total. It began in 2026-02-02 with a primary completion date of 2027-02-14.

Brief Summary

This Phase 3 study evaluates the efficacy and safety of once-weekly subcutaneous tirzepatide (a dual GIP and GLP-1 receptor agonist) at 5 mg, 10 mg, or 15 mg versus placebo, each used with a reduced-calorie diet and increased physical activity, in adults without type 2 diabetes who have obesity or are overweight with weight-related comorbidities. The primary efficacy assessment is at Week 72. Participants with prediabetes at randomization may continue in an additional long-term treatment period to assess progression to type 2 diabetes and longer-term weight outcomes.

Eligibility Criteria

Inclusion Criteria: * BMI ≥30 kg/m², OR BMI ≥27 kg/m² with ≥1 weight-related comorbidity (e.g., hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease) * History of at least one unsuccessful dietary effort to lose weight (self-reported) * Investigator judges participant capable and willing to self-inject (or have assistance), follow lifestyle advice, maintain a diary, and complete questionnaires * Age ≥18 years * Meets protocol contraception/pregnancy criteria (as applicable) and provides written informed consent Exclusion Criteria: * Type 1 or type 2 diabetes, history of ketoacidosis/hyperosmolar state, or screening labs diagnostic of diabetes * Recent significant weight change (\>5 kg within 3 months prior to screening) * Prior/planned bariatric surgery; recent/ongoing endoscopic or device-based obesity therapies * Severe renal impairment (eGFR \<30 mL/min/1.73 m²) * Clinically significant gastric emptying abnormality or chronic use of drugs that directly affect GI motility * History of chronic or acute pancreatitis * Clinically significant thyroid abnormalities at screening (e.g., TSH outside protocol range) or anticipated need to initiate thyroid replacement during study * Obesity due to other endocrinologic disorders (e.g., Cushing syndrome) or monogenic/syndromic obesity (e.g., MC4R deficiency, Prader-Willi syndrome) * Significant unstable major depressive disorder/severe psychiatric disorder, lifetime suicide attempt, or concerning suicidality screening (PHQ-9/C-SSRS criteria) * Uncontrolled hypertension; recent major cardiovascular events; NYHA class IV heart failure * Active or significant liver disease or certain elevated liver tests at screening (per protocol thresholds) * Elevated calcitonin above protocol thresholds; personal/family history of medullary thyroid carcinoma or MEN2 * Active/untreated malignancy or remission \<5 years (with specified exceptions) * Any other condition contraindicating GLP-1 receptor agonist therapy

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