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

Sponsor
Hudson Biotech
Study ID
NCT07481747
Phase
PHASE3
Status
Recruiting
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Conditions

  • Obesity
  • Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    (once-weekly SC injection; doses 5/10/15 mg)
  • Placebo — DRUG
    (once-weekly SC injection)
  • Reduced-calorie diet — BEHAVIORAL
    increased physical activity counseling

Study Details

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.

Key Dates

Start date
Feb 2, 2026
Status verified
Mar 2026
Primary completion
Feb 14, 2027
Completion
Mar 17, 2028

Study Design

Enrollment
2,539 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Tirzepatide 5 mg once weekly + lifestyle intervention
  • Experimental: Arm 2: Tirzepatide 10 mg once weekly + lifestyle intervention
  • Experimental: Arm 3: Tirzepatide 15 mg once weekly + lifestyle intervention
  • Experimental: Arm 4: Placebo once weekly + lifestyle intervention

Primary Outcome Measure

Mean percent change in body weight from randomization [ Time Frame: 72 Weeks ]

Central Contacts

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