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

NCT07481747
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
2,539
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Lead sponsor
Hudson Biotech
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Start date
2026-02-02
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Number of sites
1
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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.
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Acronym
SURMOUNT-1
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Short title
Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo in Participants Who Are Either Obese or Overweight With Weight-Related Comorbidities (SURMOUNT-1)
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Official title
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)
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2028-03-17
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First posted
2026-03-19
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Registry last updated
2026-03-19
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Primary completion date
2027-02-14
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Start date
2026-02-02
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Participants
2,539
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Participant count basis
Estimated
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Planned participants
2,539
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Protocol amendments
0
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Randomisation ratio
1:1:1:1
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Number of sites
1
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Hudson Biotech
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07481747
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ClinicalTrials.gov ID
NCT07481747
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masking description
Participants and investigators are blinded to treatment assignment. Study drug and placebo are administered using similar autoinjector pens; randomization and drug dispensing are managed centrally via an interactive system.
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Mean percent change in body weight from randomization

    Timeframe: 72 Weeks

  2. Percentage of participants achieving ≥5% body weight reduction from randomization

    Timeframe: 72 Weeks

  1. Mean change in body weight

    Timeframe: 72 Weeks

    Mean change in body weight (kg) from randomization (pooled 10 mg and 15mg vs placebo)

  2. Changes in cardiometabolic measures in triglycerides

    Timeframe: 72 weeks

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
clinicaltrials.gov

  • Peking University Shenzhen HospitalShenzhen, ChinaRecruiting
Sources for sites
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Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (2)