New weekly shot shows promise for major weight loss in obesity trial
NCT ID NCT07467447
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new once-weekly injection called retatrutide (LY3437943) to help people with obesity or overweight who also have weight-related health problems like high blood pressure or high cholesterol. About 300 adults will receive either the drug or a placebo, along with diet and exercise advice. The main goal is to see how much weight they lose after 24 weeks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Feb 2026
- Expected to finish
-
Feb 2028
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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 (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).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Obesity are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Peking University Shenzhen Hospital
RECRUITINGShenzhen, Guangdong, 518036, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Custom knee guides put to the test in obese patients
- A pill for obesity? early human trial puts MDR-001 to the test
- Can a weekly shot help people who still struggle with weight after bariatric surgery?
- Do GLP-1 Weight-Loss drugs change how teens eat and feel?
- Can electrical muscle stimulation boost exercise benefits after menopause?
- Can a cold cloth on the neck calm Post-Surgery nausea?