Actively Recruiting
Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo in Participants Who Are Either Obese or Overweight With Weight-Related Comorbidities (SURMOUNT-1)
Led by Hudson Biotech · Updated on 2026-03-19
2539
Participants Needed
1
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo in Participants Who Are Either Obese or Overweight With Weight-Related Comorbidities (SURMOUNT-1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Body mass index (BMI) of 30 kg/m² or higher, or BMI of 27 kg/m² or higher with at least one weight-related health condition such as hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease
- History of at least one unsuccessful attempt to lose weight through diet (self-reported)
- Ability and willingness to self-inject tirzepatide or receive assistance
- Willingness to follow lifestyle advice including reduced-calorie diet and increased physical activity
- Willingness to maintain a diary and complete questionnaires
- Meets contraception and pregnancy requirements if applicable
- Provides written informed consent
You will not qualify if you...
- Diagnosis of type 1 or type 2 diabetes, history of ketoacidosis or hyperosmolar state, or laboratory tests indicating diabetes at screening
- Significant weight change greater than 5 kg within 3 months before screening
- Previous or planned bariatric surgery or recent/ongoing endoscopic or device-based obesity treatments
- Severe kidney impairment with eGFR below 30 mL/min/1.73 m²
- Serious gastric emptying problems or chronic use of drugs affecting gastrointestinal motility
- History of chronic or acute pancreatitis
- Clinically significant thyroid problems at screening or expected need for thyroid replacement during the study
- Obesity caused by other endocrine disorders or genetic syndromes such as Cushing syndrome, MC4R deficiency, or Prader-Willi syndrome
- Unstable major depressive disorder, severe psychiatric disorder, past suicide attempts, or concerning suicidality
- Uncontrolled high blood pressure, recent major heart events, or severe heart failure (NYHA class IV)
- Active or serious liver disease or elevated liver tests beyond protocol limits
- Elevated calcitonin levels or personal/family history of medullary thyroid carcinoma or MEN2
- Active or untreated cancer or cancer remission less than 5 years except specified exceptions
- Any other condition that makes GLP-1 receptor agonist therapy unsafe or unsuitable
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Actively Recruiting
Research Team
S
Seni S Lu, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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