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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: Placebo; Drug: LY3437943

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32804
      • AdventHealth Orlando
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo administered SC	Other: Placebo; Administered SC
Experimental: LY3437943; LY3437943 administered subcutaneously (SC)	Drug: LY3437943; Administered SC

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Actual): August 26, 2025
• Study Completion (Actual): August 26, 2025

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Diet; Food
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; retatrutide
• Other Study ID Numbers: 18726; J1I-MC-GZBW (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No