BridgeMD
Compares treatment options for Obesity
Official title Effect of LY3437943 Versus Placebo in Participants Who Have Obesity or Are Overweight
ClinicalTrials.gov ID: NCT07467447
What this study is testing
What is Retatrutide (LY3437943)?
Retatrutide (LY3437943) is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for obesity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Motivated and able/willing to self-inject (or have trained assistance if needed) and follow study procedures, including lifestyle advice and...
- 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...
You likely can't join if
- 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...
- Renal impairment: eGFR \<45 mL/min/1.73 m² (CKD-EPI) at screening.
See the full eligibility criteria
Who can 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.
What rules you out
- 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.
- 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Shenzhen, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenzhen, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.