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

NCT06313528 | Completed Phase 1 FDA Drug

• 2 other identifiers: 18726J1I-MC-GZBW
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 3

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.

Conditions

Obesity

Keywords

Food; Diet

Outcome Measures

Primary Outcomes (1)

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

  Baseline up to Week 17 (inclusive)

Secondary Outcomes (7)

• Change from Baseline in Sleep Metabolic Rate (SMR)

  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)

  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)

Study Arms (2)

LY3437943

EXPERIMENTAL

LY3437943 administered subcutaneously (SC)

Drug: LY3437943

Placebo

PLACEBO COMPARATOR

Placebo administered SC

Other: Placebo

Interventions

LY3437943 DRUG

Administered SC

LY3437943

Placebo OTHER

Administered SC

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BMI greater than 30 kg/m2
• History of at least 1 self-reported unsuccessful dietary effort to reduce body weight

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

AdventHealth Orlando

Orlando, Florida, 32804, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Links

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

MeSH Terms

Conditions

Obesity

Interventions

retatrutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Sponsor-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 15, 2024
• Study Start: March 20, 2024
• Primary Completion: August 26, 2025
• Study Completion: August 26, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)