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)
Efficacy and Safety of Tirzepate in Obesity
Plain English Summary
Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo in Participants Who Are Either Obese or Overweight With Weight-Related Comorbidities (SURMOUNT-1) is a Phase 3 clinical trial sponsored by Hudson Biotech studying Obesity, Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities. Tests the effectiveness and safety of Tirzepate, a once-weekly injection, for weight loss in obese or overweight adults without type 2 diabetes. For adults with obesity or overweight status and related health issues, who have tried dieting before. Participation involves weekly injections, following a reduced-calorie diet, and increased physical activity. Alternatives include lifestyle changes, dieting, and other weight loss medications. The trial aims to enroll 2539 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults with a BMI of 30 kg/m² or higher, or 27 kg/m² with at least one weight-related health issue like high blood pressure or sleep apnea, can join. Those with diabetes, recent significant weight loss, or certain medical conditions like severe kidney problems or recent bariatric surgery cannot join. This trial is studying Obesity, Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures show how much weight participants lose and how many achieve a 5% weight reduction, which can improve overall health. The specific primary outcome measures are: Mean percent change in body weight from randomization (72 Weeks); Percentage of participants achieving ≥5% body weight reduction from randomization (72 Weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial addresses the gap in effective treatments for obesity, offering a new option that combines the benefits of two weight loss mechanisms. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Obesity, Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities, where improved treatment options are needed.
Investor Insight
The large market size and growing need for effective obesity treatments make this trial significant, with a high probability of approval. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 2539 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if you meet the eligibility criteria and if Tirzepate is right for you. You will need to follow a reduced-calorie diet and increase physical activity, and keep a daily diary. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: DOUBLE
- Enrollment: 2,539 participants
Interventions
- DRUG: Tirzepatide — (once-weekly SC injection; doses 5/10/15 mg)
- DRUG: Placebo — (once-weekly SC injection)
- BEHAVIORAL: Reduced-calorie diet — increased physical activity counseling
Primary Outcomes
- Mean percent change in body weight from randomization (72 Weeks)
- Percentage of participants achieving ≥5% body weight reduction from randomization (72 Weeks)
Secondary Outcomes
- Mean change in body weight (72 Weeks)
- Changes in cardiometabolic measures in triglycerides (72 weeks)
Full Eligibility Criteria
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
Trial Locations
- Peking University Shenzhen Hospital, Shenzhen, Guangdong, China
Frequently Asked Questions
What is clinical trial NCT07481747?
NCT07481747 is a Phase 3 INTERVENTIONAL study titled "Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo in Participants Who Are Either Obese or Overweight With Weight-Related Comorbidities (SURMOUNT-1)." It is currently recruiting and is sponsored by Hudson Biotech. The trial targets enrollment of 2539 participants.
What conditions does NCT07481747 study?
This trial investigates treatments for Obesity, Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities. The primary condition under study is Obesity.
What treatments are being tested in NCT07481747?
The interventions being studied include: Tirzepatide (DRUG), Placebo (DRUG), Reduced-calorie diet (BEHAVIORAL). (once-weekly SC injection; doses 5/10/15 mg)
What does Phase 3 mean for NCT07481747?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT07481747?
This trial is currently "Recruiting." It started on 2026-02-02. The estimated completion date is 2028-03-17.
Who is sponsoring NCT07481747?
NCT07481747 is sponsored by Hudson Biotech. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07481747?
The trial aims to enroll 2539 participants. The trial is currently recruiting and accepting new participants.
How is NCT07481747 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs double masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT07481747?
The primary outcome measures are: Mean percent change in body weight from randomization (72 Weeks); Percentage of participants achieving ≥5% body weight reduction from randomization (72 Weeks). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07481747 being conducted?
This trial is being conducted at 1 site, including Shenzhen, Guangdong (China).
Where can I find official information about NCT07481747?
The official record for NCT07481747 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07481747. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07481747 testing in simple terms?
Tests the effectiveness and safety of Tirzepate, a once-weekly injection, for weight loss in obese or overweight adults without type 2 diabetes. For adults with obesity or overweight status and related health issues, who have tried dieting before.
Why is this trial significant?
This trial addresses the gap in effective treatments for obesity, offering a new option that combines the benefits of two weight loss mechanisms. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT07481747?
Potential side effects include nausea, vomiting, and diarrhea, which are common with weight loss medications. Monitor your blood sugar levels and report any unusual symptoms to your healthcare provider. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07481747?
Ask your doctor if you meet the eligibility criteria and if Tirzepate is right for you. You will need to follow a reduced-calorie diet and increase physical activity, and keep a daily diary. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07481747 signal from an investment perspective?
The large market size and growing need for effective obesity treatments make this trial significant, with a high probability of approval. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participation involves weekly injections, following a reduced-calorie diet, and increased physical activity. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.