ObesityPhase 3SURMOUNT-1NCT07481747
Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo in Participants Who Are Either Obese or Overweight With Weight-Related Comorbidities (SURMOUNT-1)
A Phase 3 study testing Tirzepatide and Reduced-calorie diet in people with Obesity and Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities, run by Hudson Biotech at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities
- What is being tested?
- Tirzepatide and Reduced-calorie diet
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,539 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2026to 17 Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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 and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Zhen J Peng, Phd, +86 13076790039, Zhen-Peng@beijing-biotech.com
About this study
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)
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.
Read the detailed description
After screening, eligible participants are randomized in a 1:1:1:1 ratio to receive tirzepatide 5 mg, 10 mg, 15 mg, or placebo once weekly by subcutaneous injection using an autoinjector. All participants receive lifestyle counseling focused on a reduced-calorie diet and increased physical activity. The main treatment period is 72 weeks. Participants identified with prediabetes at randomization can continue study treatment for up to 176 weeks (plus follow-up), allowing evaluation of longer-term weight management and time to onset/progression to type 2 diabetes. Safety is monitored throughout, including adverse events and laboratory testing.
- Being tested
- Tirzepatide, Placebo, Reduced-calorie diet
- Keywords
- Tirzepatide, LY3298176, dual incretin, GIP, GLP-1, obesity, overweight, weight management, placebo, randomized, double-blind, once-weekly, subcutaneous, lifestyle intervention
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
(once-weekly SC injection; doses 5/10/15 mg)
PlaceboDrug
(once-weekly SC injection)
Reduced-calorie dietBehavioural
increased physical activity counseling
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Tirzepatide 5 mg once weekly + lifestyle intervention | Experimental | Not described Receives: Drug: Tirzepatide; Drug: Placebo; Behavioral: Reduced-calorie diet |
| Arm 2: Tirzepatide 10 mg once weekly + lifestyle intervention | Experimental | Not described Receives: Drug: Tirzepatide; Drug: Placebo; Behavioral: Reduced-calorie diet |
| Arm 3: Tirzepatide 15 mg once weekly + lifestyle intervention | Experimental | Not described Receives: Drug: Tirzepatide; Drug: Placebo; Behavioral: Reduced-calorie diet |
| Arm 4: Placebo once weekly + lifestyle intervention | Experimental | Not described Receives: Drug: Tirzepatide; Drug: Placebo; Behavioral: Reduced-calorie diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean percent change in body weight from randomization
Measured: 72 Weeks
Percentage of participants achieving ≥5% body weight reduction from randomization
Measured: 72 Weeks
Secondary outcomes (2)
Mean change in body weight
Mean change in body weight (kg) from randomization (pooled 10 mg and 15mg vs placebo)
Measured: 72 Weeks
Changes in cardiometabolic measures in triglycerides
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start2 Feb 2026
- Primary completion14 Feb 2027 (estimated)
- Study completion17 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group, 4-arm study. Participants randomized 1:1:1:1 to tirzepatide 5 mg, 10 mg, 15 mg, or placebo once weekly, plus lifestyle intervention. Main evaluation at 72 weeks; participants with prediabetes may continue treatment up to 176 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,539 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hudson Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481747
- Sponsor's protocol ID
- I8F-MC-GPHK(b)
- Acronym
- SURMOUNT-1
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07481747
- Acronym / sponsor ID
- SURMOUNT-1 / I8F-MC-GPHK(b)
- Keywords
- Tirzepatide, LY3298176, dual incretin, GIP, GLP-1, obesity, overweight, weight management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,539 participants (estimated)
- Lead sponsor
- Hudson BiotechIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 14 Feb 2027 (estimated)
- Study completion
- 17 Mar 2028 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After screening, eligible participants are randomized in a 1:1:1:1 ratio to receive tirzepatide 5 mg, 10 mg, 15 mg, or placebo once weekly by subcutaneous injection using an autoinjector. All participants receive lifestyle counseling focused on a reduced-calorie diet and increased physical activity. The main treatment period is 72 weeks. Participants identified with prediabetes at randomization can continue study treatment for up to 176 weeks (plus follow-up), allowing evaluation of longer-term weight management and time to onset/progression to type 2 diabetes. Safety is monitored throughout, including adverse events and laboratory testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Parallel group, 4-arm study. Participants randomized 1:1:1:1 to tirzepatide 5 mg, 10 mg, 15 mg, or placebo once weekly, plus lifestyle intervention. Main evaluation at 72 weeks; participants with prediabetes may continue treatment up to 176 weeks.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Tirzepatide 5 mg once weekly + lifestyle intervention | Experimental | Drug: Tirzepatide, Drug: Placebo, Behavioral: Reduced-calorie diet |
| Arm 2: Tirzepatide 10 mg once weekly + lifestyle intervention | Experimental | Drug: Tirzepatide, Drug: Placebo, Behavioral: Reduced-calorie diet |
| Arm 3: Tirzepatide 15 mg once weekly + lifestyle intervention | Experimental | Drug: Tirzepatide, Drug: Placebo, Behavioral: Reduced-calorie diet |
| Arm 4: Placebo once weekly + lifestyle intervention | Experimental | Drug: Tirzepatide, Drug: Placebo, Behavioral: Reduced-calorie diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tirzepatide(once-weekly SC injection; doses 5/10/15 mg) | Drug | Arm 1: Tirzepatide 5 mg once weekly + lifestyle intervention, Arm 2: Tirzepatide 10 mg once weekly + lifestyle intervention, Arm 3: Tirzepatide 15 mg once weekly + lifestyle intervention, Arm 4: Placebo once weekly + lifestyle intervention |
| Placebo(once-weekly SC injection) | Drug | Arm 1: Tirzepatide 5 mg once weekly + lifestyle intervention, Arm 2: Tirzepatide 10 mg once weekly + lifestyle intervention, Arm 3: Tirzepatide 15 mg once weekly + lifestyle intervention, Arm 4: Placebo once weekly + lifestyle intervention |
| Reduced-calorie dietincreased physical activity counseling | Behavioural | Arm 1: Tirzepatide 5 mg once weekly + lifestyle intervention, Arm 2: Tirzepatide 10 mg once weekly + lifestyle intervention, Arm 3: Tirzepatide 15 mg once weekly + lifestyle intervention, Arm 4: Placebo once weekly + lifestyle intervention |
Primary outcome
Mean percent change in body weight from randomization
Time frame: 72 Weeks
Percentage of participants achieving ≥5% body weight reduction from randomization
Time frame: 72 Weeks
2 secondary outcomes
Mean change in body weight
Time frame: 72 Weeks
Changes in cardiometabolic measures in triglycerides
Time frame: 72 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tirzepatide and Reduced-calorie diet in people with Obesity and Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities, run by Hudson Biotech at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seni S Lu, Phd (+86 13076790030, Seni-Lu@beijing-biotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean percent change in body weight from randomization (time frame: 72 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.