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.
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
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)
Parallel
Tirzepatide
Drug(once-weekly SC injection; doses 5/10/15 mg)
Placebo
Drug(once-weekly SC injection)
Reduced-calorie diet
Behavioralincreased physical activity counseling
Mean percent change in body weight from randomization
Percentage of participants achieving ≥5% body weight reduction from randomization
Mean change in body weight
Mean change in body weight (kg) from randomization (pooled 10 mg and 15mg vs placebo)
Changes in cardiometabolic measures in triglycerides
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