ObesityPhase 2GZBFNCT07467447
Effect of LY3437943 Versus Placebo in Participants Who Have Obesity or Are Overweight
A Phase 2 study testing Retatrutide (LY3437943) and Standardized diet and physical activity counseling throughout the study. in people with Obesity, run by Hudson Biotech at 1 site in China.
Trial summary
Phase 2, multicenter, randomized, double-blind, placebo-controlled study evaluating once-weekly subcutaneous retatrutide (LY3437943) at multiple maintenance dose levels versus placebo in adults with obesity or overweight with weight-related comorbidities (without type 2 diabetes), alongside standardized diet and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- Retatrutide (LY3437943) and Standardized diet and physical activity counseling throughout the study.
- 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
- 300 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2026to 17 Feb 2028
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years (inclusive) at time of informed consent.
- BMI ≥30 and ≤50 kg/m², OR BMI ≥27 and <30 kg/m² with at least 1 weight-related comorbidity (hypertension; dyslipidemia; or cardiovascular disease such as ischemic CVD or NYHA Class I-II heart failure).
- Motivated and able/willing to self-inject (or have trained assistance if needed) and follow study procedures, including lifestyle advice and questionnaires.
- Subgroup (NAFLD addendum): liver fat content ≥10% by MRI-PDFF (for participants invited to the addendum).
- Male and/or female; contraception requirements apply; women of childbearing potential must have negative pregnancy tests at specified visits and should not be breastfeeding.
- Capable of giving signed informed consent and complying with protocol requirements.
Who cannot join
- History of diabetes mellitus (type 1 or type 2), ketoacidosis, or hyperosmolar state/coma.
- Screening lab values suggestive of diabetes (HbA1c ≥6.5%; fasting glucose ≥126 mg/dL; or random glucose ≥200 mg/dL).
- Self-reported change in body weight >5 kg within 3 months prior to screening.
- Prior or planned surgical treatment for obesity (exceptions: liposuction/abdominoplasty >1 year prior).
- Current/planned endoscopic or device-based obesity therapy, or device removal within last 6 months (e.g., intragastric balloon, gastric artery embolization).
- Renal impairment: eGFR <45 mL/min/1.73 m² (CKD-EPI) at screening.
Show all 36Show fewer
- Clinically significant gastric emptying abnormality (e.g., severe gastroparesis) or chronic drugs affecting GI motility.
- History of acute or chronic pancreatitis (exception for resolved gallstone pancreatitis post-cholecystectomy).
- TSH outside 0.4 to 6.0 mIU/L at screening (with protocol-defined exceptions).
- Obesity due to other endocrine disorders (e.g., Cushing's) or monogenic/syndromic obesity (e.g., Prader-Willi).
- Psychiatric exclusion criteria including unstable major depressive disorder/severe psychiatric disorder within 2 years; lifetime suicide attempt; PHQ-9 score ≥15; or specified Columbia-Suicide Severity Rating Scale (C-SSRS) findings within past month.
- Uncontrolled hypertension (systolic ≥160 mmHg and/or diastolic ≥100 mmHg) or elevated resting pulse rate (>100 bpm) at baseline.
- Recent (within 3 months) major cardiovascular events (e.g., MI, stroke, unstable angina, CHF hospitalization); tachyarrhythmia syndromes; NYHA Class III-IV CHF; or ECG abnormalities interfering with interpretation.
- Acute/chronic hepatitis or liver disease other than NAFLD; or screening labs: ALT >3× ULN, ALP >1.5× ULN, or total bilirubin >1.5× ULN (with exception).
- Elevated calcitonin at Visit 1 per protocol thresholds; personal/family history of medullary thyroid carcinoma or MEN2.
- Active/untreated malignancy or remission <5 years (with protocol exceptions for certain in-situ/skin cancers).
- Contraindication to GLP-1 receptor agonists, or other conditions that could prevent protocol compliance (including drug/alcohol abuse or eating disorder), per investigator judgment.
- Alcohol consumption >14 units/week (women) or >21 units/week (men).
- Recent marijuana/THC-containing product use within 3 months or unwillingness to abstain during trial (protocol exception for cannabidiol oil if agrees to refrain).
- Organ transplant history (except corneal transplant) or awaiting transplant.
- Hematologic conditions interfering with HbA1c measurement; recent large blood donation/transfusion/severe blood loss; hemoglobin below protocol thresholds.
- Severe atopy/multiple severe allergies or severe hypersensitivity reactions.
- Fasting triglycerides >500 mg/dL at screening (with stability requirement for lipid-lowering therapy).
- Significant active, uncontrolled medical condition or history posing risk or interfering with data interpretation, per investigator judgment.
- History of symptomatic gallbladder disease within past 2 years (protocol-defined exceptions after cholecystectomy).
- History of documented HIV infection.
- Chronic systemic glucocorticoid therapy within 3 months or active autoimmune abnormality likely to require systemic steroids during study (with specified formulation exceptions).
- Recent medications that may cause significant weight gain (e.g., tricyclic antidepressants, atypical antipsychotics, mood stabilizers) within 3 months.
- Recent use (within 3 months) of medications or remedies intended to promote weight loss (examples listed in protocol, including GLP-1 RAs).
- Use of metformin or other glucose-lowering medications (e.g., for PCOS or diabetes prevention) not permitted at entry.
- Started implantable/injectable contraceptives within 18 months prior to screening (IUDs allowed if used ≥3 months).
- Known allergies to GLP-1 receptor agonists or LY3437943.
- Currently enrolled in another investigational study or recent participation/treatment within 30 days (or 5 half-lives, whichever longer).
- Previously received LY3437943 in this or another study.
- Investigator site personnel directly affiliated with the study and/or their immediate family; or Lilly employees.
- Note: The publicly posted protocol references additional exclusion criteria numbered 52-57 in a separate protocol addendum (not included in the posted protocol PDF).
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, +8613076790039, Zhen-Peng@beijing-biotech.com
About this study
Official title: A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities
Phase 2, multicenter, randomized, double-blind, placebo-controlled study evaluating once-weekly subcutaneous retatrutide (LY3437943) at multiple maintenance dose levels versus placebo in adults with obesity or overweight with weight-related comorbidities (without type 2 diabetes), alongside standardized diet and physical activity counseling.
Read the detailed description
After screening (up to 6 weeks), eligible participants are randomized to one of several dose-escalation regimens leading to maintenance doses of 1, 4, 8, or 12 mg retatrutide (or placebo) administered once weekly for 48 weeks, followed by a 4-week safety follow-up. Two maintenance dose levels (4 mg and 8 mg) include alternative escalation schedules to evaluate tolerability. The primary efficacy evaluation is at Week 24 (percent change in body weight), with additional weight, anthropometric, and safety assessments through Week 48.
- Conditions
- Obesity
- Being tested
- Retatrutide (LY3437943), Placebo, Standardized diet and physical activity counseling throughout the study.
- Keywords
- Retatrutide, LY3437943, triple agonist, GIP receptor agonist, GLP-1 receptor agonist, glucagon receptor agonist, weight loss, body weight, BMI, waist circumference, lifestyle counseling
- Medical subject headings
- Obesity, Weight Loss, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retatrutide (LY3437943)Drug
subcutaneous injection, once weekly (dose per assigned arm).
PlaceboDrug
subcutaneous injection, once weekly (schedule matched to an active arm).
Standardized diet and physical activity counseling throughout the study.Behavioural
Standardized diet and physical activity counseling throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Retatrutide (LY3437943) 1 mg once weekly (no escalation) | Experimental | Not described Receives: Drug: Retatrutide (LY3437943); Drug: Placebo; Behavioral: Standardized diet and physical activity counseling throughout the study. |
| Retatrutide 4 mg once weekly, escalation subgroup (a): 2 mg → 4 mg. | Experimental | Not described Receives: Drug: Retatrutide (LY3437943); Drug: Placebo; Behavioral: Standardized diet and physical activity counseling throughout the study. |
| Retatrutide 4 mg once weekly, subgroup (b): start 4 mg (no escalation). | Experimental | Not described Receives: Drug: Retatrutide (LY3437943); Drug: Placebo; Behavioral: Standardized diet and physical activity counseling throughout the study. |
| Retatrutide 8 mg once weekly, subgroup (a): 2 mg → 4 mg → 8 mg | Experimental | Not described Receives: Drug: Retatrutide (LY3437943); Drug: Placebo; Behavioral: Standardized diet and physical activity counseling throughout the study. |
| Retatrutide 12 mg once weekly: 2 mg → 4 mg → 8 mg → 12 mg. | Experimental | Not described Receives: Drug: Retatrutide (LY3437943); Drug: Placebo; Behavioral: Standardized diet and physical activity counseling throughout the study. |
| Placebo once weekly (matched escalation schedule to maintain blinding). | Experimental | Not described Receives: Drug: Retatrutide (LY3437943); Drug: Placebo; Behavioral: Standardized diet and physical activity counseling throughout the study. |
| Retatrutide 8 mg once weekly, subgroup (b): 4 mg → 8 mg. | Experimental | Not described Receives: Drug: Retatrutide (LY3437943); Drug: Placebo; Behavioral: Standardized diet and physical activity counseling throughout the study. |
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/baseline to Week 24.
Measured: 24 weeks
Secondary outcomes (6)
Mean percent change in body weight from baseline to Week 48
Measured: 48 weeks
Proportion of participants achieving ≥5%, ≥10%, and ≥15% body weight reduction at Weeks 24 and 48.
Measured: 48 weeks
Mean change in body weight (kg) at Weeks 24 and 48.
Measured: 48 weeks
Mean change in BMI (kg/m²) at Weeks 24 and 48.
Measured: 48 weeks
Mean change in waist circumference (cm) at Weeks 24 and 48
Measured: 48 weeks
Safety and tolerability outcomes (e.g., treatment-emergent adverse events; serious adverse events; discontinuations due to adverse events).
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start15 Feb 2026
- Primary completion14 Mar 2027 (estimated)
- Study completion17 Feb 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants randomized to once-weekly subcutaneous retatrutide dose regimens (with dose escalation for selected arms) or placebo for 48 weeks, with standardized lifestyle counseling throughout.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 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
- NCT07467447
- Sponsor's protocol ID
- J1I-MC-GZBF
- Acronym
- GZBF
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 12 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 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities
- ClinicalTrials.gov ID
- NCT07467447
- Acronym / sponsor ID
- GZBF / J1I-MC-GZBF
- Conditions
- Obesity
- Keywords
- Retatrutide, LY3437943, triple agonist, GIP receptor agonist, GLP-1 receptor agonist, glucagon receptor agonist, weight loss, body weight
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hudson BiotechIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 14 Mar 2027 (estimated)
- Study completion
- 17 Feb 2028 (estimated)
- First posted
- 12 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.
Phase 2, multicenter, randomized, double-blind, placebo-controlled study evaluating once-weekly subcutaneous retatrutide (LY3437943) at multiple maintenance dose levels versus placebo in adults with obesity or overweight with weight-related comorbidities (without type 2 diabetes), alongside standardized diet and physical activity counseling.
Detailed description
After screening (up to 6 weeks), eligible participants are randomized to one of several dose-escalation regimens leading to maintenance doses of 1, 4, 8, or 12 mg retatrutide (or placebo) administered once weekly for 48 weeks, followed by a 4-week safety follow-up. Two maintenance dose levels (4 mg and 8 mg) include alternative escalation schedules to evaluate tolerability. The primary efficacy evaluation is at Week 24 (percent change in body weight), with additional weight, anthropometric, and safety assessments through Week 48.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 7
- Model description
- Participants randomized to once-weekly subcutaneous retatrutide dose regimens (with dose escalation for selected arms) or placebo for 48 weeks, with standardized lifestyle counseling throughout.
| Arm | Type | Receives |
|---|---|---|
| Retatrutide (LY3437943) 1 mg once weekly (no escalation) | Experimental | Drug: Retatrutide (LY3437943), Drug: Placebo, Behavioral: Standardized diet and physical activity counseling throughout the study. |
| Retatrutide 4 mg once weekly, escalation subgroup (a): 2 mg → 4 mg. | Experimental | Drug: Retatrutide (LY3437943), Drug: Placebo, Behavioral: Standardized diet and physical activity counseling throughout the study. |
| Retatrutide 4 mg once weekly, subgroup (b): start 4 mg (no escalation). | Experimental | Drug: Retatrutide (LY3437943), Drug: Placebo, Behavioral: Standardized diet and physical activity counseling throughout the study. |
| Retatrutide 8 mg once weekly, subgroup (a): 2 mg → 4 mg → 8 mg | Experimental | Drug: Retatrutide (LY3437943), Drug: Placebo, Behavioral: Standardized diet and physical activity counseling throughout the study. |
| Retatrutide 12 mg once weekly: 2 mg → 4 mg → 8 mg → 12 mg. | Experimental | Drug: Retatrutide (LY3437943), Drug: Placebo, Behavioral: Standardized diet and physical activity counseling throughout the study. |
| Placebo once weekly (matched escalation schedule to maintain blinding). | Experimental | Drug: Retatrutide (LY3437943), Drug: Placebo, Behavioral: Standardized diet and physical activity counseling throughout the study. |
| Retatrutide 8 mg once weekly, subgroup (b): 4 mg → 8 mg. | Experimental | Drug: Retatrutide (LY3437943), Drug: Placebo, Behavioral: Standardized diet and physical activity counseling throughout the study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 to 75 years (inclusive) at time of informed consent.
- BMI ≥30 and ≤50 kg/m², OR BMI ≥27 and <30 kg/m² with at least 1 weight-related comorbidity (hypertension; dyslipidemia; or cardiovascular disease such as ischemic CVD or NYHA Class I-II heart failure).
- Motivated and able/willing to self-inject (or have trained assistance if needed) and follow study procedures, including lifestyle advice and questionnaires.
- Subgroup (NAFLD addendum): liver fat content ≥10% by MRI-PDFF (for participants invited to the addendum).
- Male and/or female; contraception requirements apply; women of childbearing potential must have negative pregnancy tests at specified visits and should not be breastfeeding.
Key exclusion criteria (36 listed)
- History of diabetes mellitus (type 1 or type 2), ketoacidosis, or hyperosmolar state/coma.
- Screening lab values suggestive of diabetes (HbA1c ≥6.5%; fasting glucose ≥126 mg/dL; or random glucose ≥200 mg/dL).
- Self-reported change in body weight >5 kg within 3 months prior to screening.
- Prior or planned surgical treatment for obesity (exceptions: liposuction/abdominoplasty >1 year prior).
- Current/planned endoscopic or device-based obesity therapy, or device removal within last 6 months (e.g., intragastric balloon, gastric artery embolization).
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 |
|---|---|---|
| Retatrutide (LY3437943)subcutaneous injection, once weekly (dose per assigned arm). | Drug | Placebo once weekly (matched escalation schedule to maintain blinding)., Retatrutide (LY3437943) 1 mg once weekly (no escalation), Retatrutide 12 mg once weekly: 2 mg → 4 mg → 8 mg → 12 mg., Retatrutide 4 mg once weekly, escalation subgroup (a): 2 mg → 4 mg., Retatrutide 4 mg once weekly, subgroup (b): start 4 mg (no escalation)., Retatrutide 8 mg once weekly, subgroup (a): 2 mg → 4 mg → 8 mg, Retatrutide 8 mg once weekly, subgroup (b): 4 mg → 8 mg. |
| Placebosubcutaneous injection, once weekly (schedule matched to an active arm). | Drug | Placebo once weekly (matched escalation schedule to maintain blinding)., Retatrutide (LY3437943) 1 mg once weekly (no escalation), Retatrutide 12 mg once weekly: 2 mg → 4 mg → 8 mg → 12 mg., Retatrutide 4 mg once weekly, escalation subgroup (a): 2 mg → 4 mg., Retatrutide 4 mg once weekly, subgroup (b): start 4 mg (no escalation)., Retatrutide 8 mg once weekly, subgroup (a): 2 mg → 4 mg → 8 mg, Retatrutide 8 mg once weekly, subgroup (b): 4 mg → 8 mg. |
| Standardized diet and physical activity counseling throughout the study.Standardized diet and physical activity counseling throughout the study. | Behavioural | Placebo once weekly (matched escalation schedule to maintain blinding)., Retatrutide (LY3437943) 1 mg once weekly (no escalation), Retatrutide 12 mg once weekly: 2 mg → 4 mg → 8 mg → 12 mg., Retatrutide 4 mg once weekly, escalation subgroup (a): 2 mg → 4 mg., Retatrutide 4 mg once weekly, subgroup (b): start 4 mg (no escalation)., Retatrutide 8 mg once weekly, subgroup (a): 2 mg → 4 mg → 8 mg, Retatrutide 8 mg once weekly, subgroup (b): 4 mg → 8 mg. |
Primary outcome
Mean percent change in body weight from randomization/baseline to Week 24.
Time frame: 24 weeks
6 secondary outcomes
Mean percent change in body weight from baseline to Week 48
Time frame: 48 weeks
Proportion of participants achieving ≥5%, ≥10%, and ≥15% body weight reduction at Weeks 24 and 48.
Time frame: 48 weeks
Mean change in body weight (kg) at Weeks 24 and 48.
Time frame: 48 weeks
Mean change in BMI (kg/m²) at Weeks 24 and 48.
Time frame: 48 weeks
Mean change in waist circumference (cm) at Weeks 24 and 48
Time frame: 48 weeks
Safety and tolerability outcomes (e.g., treatment-emergent adverse events; serious adverse events; discontinuations due to adverse events).
Time frame: 48 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 12 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 2 study testing Retatrutide (LY3437943) and Standardized diet and physical activity counseling throughout the study. in people with Obesity, 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 6 inclusion and 36 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 12 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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/baseline to Week 24. (time frame: 24 weeks). 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 12 Mar 2026.