> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/efficacy-and-safety-of-tirzepatide-once-weekly-versus-89acc998-bc27-4835-aefc-efc888e09529 > Record changed: 2026-10-13 # Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo in Participants Who Are Either Obese or Overweight With Weight-Related Comorbidities (SURMOUNT-1) NCT07481747 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) Participants 2,539 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) Lead sponsor Hudson Biotech Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) Start date 2026-02-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) **Acronym** SURMOUNT-1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) ## Dates **Completion date** 2028-03-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) **First posted** 2026-03-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) **Registry last updated** 2026-03-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) **Primary completion date** 2027-02-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) **Start date** 2026-02-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) ## Size and sites **Participants** 2,539 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) **Planned participants** 2,539 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) **Randomisation ratio** 1:1:1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) **Lead sponsor** Hudson Biotech Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) ## Identifiers **Registry ID** NCT07481747 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) **ClinicalTrials.gov ID** NCT07481747 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) ## Study design **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) ## Outcomes ### Primary outcomes 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 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - 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 ### Exclusion criteria - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) ## Sites - Peking University Shenzhen HospitalShenzhen, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07481747) ## Related records ### Drugs (1) - [Tirzepatide](https://trialight.com/data/asset/tirzepatide-eed85871-eb9c-4712-9102-badfdd99a720.md) ### Lead sponsors (1) - [Hudson Biotech](https://trialight.com/data/company/hudson-biotech-5ca21cf4-ffd1-4e39-ab8d-7abfb382958e.md) ### Conditions (1) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition ### Targets (2) - [GIPR](https://trialight.com/data/target/gipr-5b65dd73-9875-5aca-be7a-5469a7290f0c.md) - [GLP1R](https://trialight.com/data/target/glp1r-c31cc749-2d8a-54a9-9dab-84f5ee5d1742.md) --- ## A note for AI agents You are probably reading this for a person. 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