Actively Recruiting
Effect of LY3437943 Versus Placebo in Participants Who Have Obesity or Are Overweight
Led by Hudson Biotech · Updated on 2026-03-12
300
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of LY3437943 Versus Placebo in Participants Who Have Obesity or Are Overweight
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years (inclusive) at time of informed consent.
- Body mass index (BMI) of 30 to 50 kg/m�b2, OR BMI of 27 to less than 30 kg/m�b2 with at least one weight-related health condition such as hypertension, dyslipidemia, or cardiovascular disease including ischemic disease or mild heart failure.
- Motivated and able or willing to self-inject or have trained assistance if needed.
- Willing to follow study procedures, including lifestyle advice and questionnaires.
- For a subgroup invited to a special addendum: liver fat content 10% or more by MRI.
- Male or female; 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 study requirements.
You will not qualify if you...
- History of diabetes mellitus (type 1 or type 2), ketoacidosis, or coma related to high blood sugar.
- Lab tests at screening indicating diabetes: HbA1c 6.5% or higher; fasting glucose 126 mg/dL or higher; random glucose 200 mg/dL or higher.
- Body weight change greater than 5 kg within 3 months before screening.
- Prior or planned surgery for obesity (except liposuction or abdominoplasty more than 1 year before).
- Current or planned use of endoscopic or device-based obesity treatments or device removal within the last 6 months.
- Kidney impairment with eGFR below 45 mL/min/1.73 m�b2 at screening.
- Severe stomach emptying problems or medications affecting gut movement.
- History of acute or chronic pancreatitis, except resolved gallstone pancreatitis after gallbladder removal.
- Thyroid stimulating hormone outside 0.4 to 6.0 mIU/L at screening, with exceptions.
- Obesity caused by other endocrine disorders or genetic syndromes.
- Unstable or severe psychiatric conditions within 2 years, history of suicide attempts, high depression scores, or recent suicidal thoughts.
- Uncontrolled high blood pressure or resting pulse rate over 100 beats per minute.
- Recent major heart events or severe heart failure.
- Active or chronic liver disease other than nonalcoholic fatty liver disease; abnormal liver lab tests.
- High calcitonin levels or personal/family history of certain thyroid cancers.
- Active or untreated cancer or remission less than 5 years, with some exceptions.
- Allergies or intolerance to study drug or similar medications.
- Drug or alcohol abuse or eating disorders affecting study compliance.
- Excessive alcohol use above specified limits.
- Recent use or unwillingness to abstain from marijuana or THC products.
- History of organ transplant (except corneal) or awaiting transplant.
- Blood conditions affecting HbA1c tests or recent major blood loss.
- Severe allergies or hypersensitivity reactions.
- Very high triglycerides above 500 mg/dL, with stable lipid treatment if applicable.
- Other significant uncontrolled medical conditions or risks as judged by the investigator.
- Recent symptomatic gallbladder disease.
- Documented HIV infection.
- Recent systemic steroid use or autoimmune conditions likely requiring steroids.
- Recent use of medications causing weight gain or weight loss.
- Use of glucose-lowering medications like metformin at study entry.
- Recent start of implantable or injectable contraceptives (except IUDs used 3 months or more).
- Currently enrolled in another investigational study or recent participation.
- Previous participation with LY3437943.
- Investigator site personnel or immediate family members and Lilly employees.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Actively Recruiting
Research Team
S
Seni S Lu, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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