Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT07467447

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China, 518036

Actively Recruiting

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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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