Tirzepatide weekly injections for weight loss in adults with obesity or overweight

Trial details

Who runs it

Hudson Biotech

Trial code

NCT07481747

Record updated

19 March 2026

Original description

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.Read full original descriptionShow less

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)

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.

Inclusion: 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: Recent significant weight change (>5 kg within 3 months prior to screening); Prior/planned bariatric surgery; recent/ongoing endoscopic or device-based obesity therapies; Clinically significant gastric emptying abnormality or chronic use of drugs that directly affect GI motility; Type 1 or type 2 diabetes, history of ketoacidosis/hyperosmolar state, or screening labs diagnostic of diabetes; History of chronic or acute pancreatitis; 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; Any other condition contraindicating GLP-1 receptor agonist therapy; Severe renal impairment (eGFR <30 mL/min/1.73 m²); Active/untreated malignancy or remission <5 years (with specified exceptions); Clinically significant thyroid abnormalities at screening (e.g., TSH outside protocol range) or anticipated need to initiate thyroid replacement during study.

ClinicalTrials.gov NCT07481747