NCT07481747RecruitingPhase 3
Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo in Participants Who Are Either Obese or Overweight With Weight-Related Comorbidities (SURMOUNT-1)
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)
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 2539 (estimated)
- First submitted
- 8 Mar 2026
- Start date
- 2 Feb 2026
- Primary completion date
- 14 Feb 2027
- Lead sponsor
- Hudson Biotech
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT07481747
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 2539
- From 2 Feb 2026 to the primary completion date, 14 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- Severe renal impairment (eGFR \<30 mL/min/1.73 m²)
Age
- Active/untreated malignancy or remission \<5 years (with specified exceptions)
Other
- Clinically significant thyroid abnormalities at screening (e.g., TSH outside protocol range) or anticipated need to initiate thyroid replacement during study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Shenzhen Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.