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

Phase 1

Active, not recruiting

• Conditions: Obesity
• Interventions: Drug: LY3437943; Other: Placebo

• Registration Number: NCT06313528
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of the study is to look at the effect of the study drug compared to placebo on calorie intake, energy metabolism, and appetite. The study will last up to 6 months and may include up to 20 visits.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-11
• Study First Submitted QC: 2024-03-11
• Study First Posted: 2024-03-15
• Study Start: 2024-03-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-27
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3437943	LY3437943	LY3437943 administered subcutaneously (SC)
Placebo	Placebo	Placebo administered SC

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Total Calorie Intake at Lunch and Dinner (Combined)	Baseline up to Week 17 (inclusive)

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Total Calorie Intake at Dinner	Baseline up to Week 17 (inclusive)
Change from Baseline in 24-hour EE	Baseline up to Week 16 (inclusive)
Change from Baseline in Total Calorie Intake at Lunch	Baseline up to Week 17 (inclusive)
Change from Baseline in Sleep Metabolic Rate (SMR)	Baseline up to Week 16 (inclusive)	In participants who achieve target weight loss
Change from Baseline in SMR	Baseline up to Week 16 (inclusive)
Change from Baseline in 24-hour Energy Expenditure (EE)	Baseline up to Week 16 (inclusive)	In participants who achieve target weight loss
Change from Baseline in Fasting Appetite Visual Analog Score (VAS)	Baseline up to Week 16 (inclusive)

Trial Locations

Locations (3)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States

AdventHealth Orlando; 🇺🇸 Orlando, Florida, United States

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States