GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Study to Measure Calorie Consumption and Usage in Participants With Obesity Using LY3437943

A Randomized, Double-Blind, Phase 1 Study to Investigate the Effect of LY3437943 Versus Placebo on Calorie Intake and Energy Expenditure in Participants With Obesity Under Calorie Restriction

Lead sponsor

Eli Lilly and Company

Asset

Retatrutide

Subcutaneous · GLP-1 / GIP / glucagon triple

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoint

•Total Calorie Intake at Lunch and Dinner (Combined)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06313528

Org study ID18726

Secondary IDJ1I-MC-GZBWEli Lilly and Company

Timeline

Milestones

Study first posted2024-03-15actual

Study start2024-03-20actual

Primary completion2025-08-26actual

Study completion2025-08-26actual

Last update posted2025-09-23actual

Assets

Investigational agents

Retatrutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age60 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•BMI greater than 30 kg/m2

•History of at least 1 self-reported unsuccessful dietary effort to reduce body weight

Exclusion criteria

•Change in body weight of greater than 5 kg (11 pounds) within 3 months prior to start of study

•Any of the following treatments for obesity within 1 year prior, or plan to undergo any of these during the study period: liposuction, cryolipolysis, or abdominoplasty

•Prior or planned bariatric or gastric sleeve surgery, endoscopic therapy, or device-based therapy for obesity

•Type 1 or Type 2 Diabetes, history of ketoacidosis, or hyperosmolar state

•Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome Type 2

•Acute or chronic hepatitis

•Had within 90 days prior: acute myocardial infarction, cerebrovascular accident (stroke), coronary artery revascularization, hospitalization for unstable angina, or hospitalization due to congestive heart failure

•History of active or unstable major depressive disorder or other severe psychiatric disorder within 2 years prior

•History of chronic or acute pancreatitis

•Blood transfusion or severe blood loss within the last 3 months or hemoglobinopathy, hemolytic anemia, sickle cell anemia

•Clinically significant multiple or severe drug allergies

•Started treatment with or changed dose within 12 months prior any medications that are associated with significant weight gain

•History of substance use disorder

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Change from Baseline in Fasting Appetite Visual Analog Score (VAS)

Time frame:Baseline up to Week 16 (inclusive)

change from baseline, improvement

Other (unclassified)

7 endpoints

Primary/protocol endpoint/low confidence

Change from Baseline in Total Calorie Intake at Lunch and Dinner (Combined)

Time frame:Baseline up to Week 17 (inclusive)

change from baseline, improvement