ClinicalTrials.gg
RecruitingNCT07467447GZBFUpdated Mar 12, 2026

Effect of LY3437943 Versus Placebo in Participants Who Have Obesity or Are Overweight

A Phase 2 interventional study of Retatrutide (LY3437943) and Placebo in Obesity, sponsored by Hudson Biotech. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-12.

Sponsored by Hudson Biotech · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 8 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Obesity

Keywords

  • Retatrutide
  • LY3437943
  • triple agonist
  • GIP receptor agonist
  • GLP-1 receptor agonist
  • glucagon receptor agonist
  • weight loss
  • body weight
  • BMI
  • waist circumference
  • lifestyle counseling
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 300 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Hudson Biotech is the lead sponsor of 8 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 to 75 years (inclusive) at time of .
  • ≥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 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; requirements apply; women of must have negative pregnancy tests at specified visits and should not be breastfeeding.
  • Capable of giving signed informed consent and complying with protocol requirements.

Exclusion criteria

Exclusion Criteria:

  • History of diabetes mellitus (type 1 or type 2), ketoacidosis, or hyperosmolar state/coma.
  • Screening lab values suggestive of diabetes ( ≥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: \<45 mL/min/1.73 m² (CKD-EPI) at screening.
  • 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; Class III-IV CHF; or abnormalities interfering with interpretation.
  • Acute/chronic hepatitis or liver disease other than NAFLD; or screening labs: >3× , ALP >1.5× ULN, or total >1.5× ULN (with exception).
  • Elevated calcitonin at Visit 1 per protocol thresholds; personal/family history of medullary thyroid carcinoma or MEN2.
  • Active/untreated or remission \<5 years (with protocol exceptions for certain in-situ/skin cancers).
  • 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; below protocol thresholds.
  • Severe atopy/multiple severe allergies or severe 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 infection.
  • Chronic systemic therapy within 3 months or active 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 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 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).
Terms in these criteria, in plain language(20)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Retatrutide (LY3437943) 1 mg once weekly (no escalation)

    Drug: Retatrutide (LY3437943) · Drug: Placebo · Behavioral: Standardized diet and physical activity counseling throughout the study.

  • Experimental
    Retatrutide 4 mg once weekly, escalation subgroup (a): 2 mg → 4 mg.

    Drug: Retatrutide (LY3437943) · Drug: Placebo · Behavioral: Standardized diet and physical activity counseling throughout the study.

  • Experimental
    Retatrutide 4 mg once weekly, subgroup (b): start 4 mg (no escalation).

    Drug: Retatrutide (LY3437943) · Drug: Placebo · Behavioral: Standardized diet and physical activity counseling throughout the study.

  • Experimental
    Retatrutide 8 mg once weekly, subgroup (a): 2 mg → 4 mg → 8 mg

    Drug: Retatrutide (LY3437943) · Drug: Placebo · Behavioral: Standardized diet and physical activity counseling throughout the study.

  • Experimental
    Retatrutide 12 mg once weekly: 2 mg → 4 mg → 8 mg → 12 mg.

    Drug: Retatrutide (LY3437943) · Drug: Placebo · Behavioral: Standardized diet and physical activity counseling throughout the study.

  • Experimental
    Placebo once weekly (matched escalation schedule to maintain blinding).

    Drug: Retatrutide (LY3437943) · Drug: Placebo · Behavioral: Standardized diet and physical activity counseling throughout the study.

  • Experimental
    Retatrutide 8 mg once weekly, subgroup (b): 4 mg → 8 mg.

    Drug: Retatrutide (LY3437943) · Drug: Placebo · Behavioral: Standardized diet and physical activity counseling throughout the study.

Interventions

  • subcutaneous injection, once weekly (dose per assigned arm).

  • DrugPlacebo

    subcutaneous injection, once weekly (schedule matched to an active arm).

  • BehavioralStandardized diet and physical activity counseling throughout the study.

    Standardized diet and physical activity counseling throughout the study.

06

What researchers measure

Primary outcomes

  1. Mean percent change in body weight from randomization/baseline to Week 24.

    Time frame: 24 weeks

Secondary outcomes

  1. Mean percent change in body weight from baseline to Week 48

    Time frame: 48 weeks

  2. Proportion of participants achieving ≥5%, ≥10%, and ≥15% body weight reduction at Weeks 24 and 48.

    Time frame: 48 weeks

  3. Mean change in body weight (kg) at Weeks 24 and 48.

    Time frame: 48 weeks

  4. Mean change in BMI (kg/m²) at Weeks 24 and 48.

    Time frame: 48 weeks

  5. Mean change in waist circumference (cm) at Weeks 24 and 48

    Time frame: 48 weeks

  6. Safety and tolerability outcomes (e.g., treatment-emergent adverse events; serious adverse events; discontinuations due to adverse events).

    Time frame: 48 weeks

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07467447
Lead sponsor
Hudson Biotech
Responsible party
Sponsor
First posted
Mar 12, 2026
Start date
Feb 15, 2026
Primary completion
Mar 14, 2027 (estimated)
Completion
Feb 17, 2028 (estimated)
Last update
Mar 12, 2026

Study contacts

Seni S Lu, Phd
Contact
Seni-Lu@beijing-biotech.com
+86 13076790030

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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