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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT06313528 (opens ClinicalTrials.gov in a new tab)Other id18726Other idJ1I-MC-GZBW
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Overview

Status
Completed
Phase
Phase 1
Enrollment
85 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
1 country

United States

Start
20 Mar 2024
Primary completion
26 Aug 2025
Completion
26 Aug 2025
First posted
15 Mar 2024
Last update posted
23 Sept 2025
Conditions
Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026
  1. Ph 1

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

    NCT06313528

    20 Mar 2024 to 26 Aug 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LY3437943Drug
  • PlaceboOther

Arms2

  • Experimental

    LY3437943

    LY3437943 administered subcutaneously (SC)

  • Placebo comparator

    Placebo

    Placebo administered SC

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Baseline up to Week 17 (inclusive)

Secondary outcomes(7)

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

    Time frame · Baseline up to Week 16 (inclusive)

    Registry description

    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)

    Registry description

    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)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 60 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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