Skip to main content
OpenTrials
Completed

NCT Number: NCT06313528

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

AdventHealth Orlando, Orlando, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3437943

Drug

Administered SC

Placebo

Other

Administered SC

Primary outcomes

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

    Time frame: Baseline up to Week 17 (inclusive)

Secondary outcomes

  1. Change from Baseline in Sleep Metabolic Rate (SMR)

    Time frame: Baseline up to Week 16 (inclusive)

    In participants who achieve target weight loss

  2. Change from Baseline in SMR

    Time frame: Baseline up to Week 16 (inclusive)

  3. Change from Baseline in 24-hour Energy Expenditure (EE)

    Time frame: Baseline up to Week 16 (inclusive)

    In participants who achieve target weight loss

  4. Change from Baseline in 24-hour EE

    Time frame: Baseline up to Week 16 (inclusive)

  5. Change from Baseline in Total Calorie Intake at Lunch

    Time frame: Baseline up to Week 17 (inclusive)

  6. Change from Baseline in Total Calorie Intake at Dinner

    Time frame: Baseline up to Week 17 (inclusive)

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

    Time frame: Baseline up to Week 16 (inclusive)

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 15, 2024
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.