Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT06313528
NCT06313528CompletedPhase 1

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

Eli Lilly and Company3 sites in 1 country85 target enrollmentStarted: March 20, 2024Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
85
Locations
3
Primary Endpoint
Change from Baseline in Total Calorie Intake at Lunch and Dinner (Combined)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Masking Description

Sponsor-blind

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

LY3437943

Experimental

LY3437943 administered subcutaneously (SC)

Intervention: LY3437943 (Drug)

Placebo

Placebo Comparator

Placebo administered SC

Intervention: Placebo (Other)

Outcomes

Primary Outcomes

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

Time Frame: Baseline up to Week 17 (inclusive)

Secondary Outcomes

  • 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))
  • 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))

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (3)

Loading locations...

Similar Trials

Completed
Phase 1
To Assess the Pharmacokinetics and Safety of Single Doses of JNJ-54452840 in Healthy Japanese and Caucasian ParticipantsHealthy
NCT01809353Janssen Research & Development, LLC32
Recruiting
Phase 1
A Study to Investigate the Safety, Tolerability, PK, and PD of CKD-508 in Healthy ParticipantsHealthy Subjects
NCT06727396Chong Kun Dang Pharmaceutical40
Completed
Phase 1
A Study to Determine the Safety, Drug Levels and Drug Effects of BMS-986196 and Food and Formulation Effects on Relative Absorption Healthy ParticipantsHealthy Participants
NCT04882150Bristol-Myers Squibb102
Completed
Phase 1
Safety, Tolerability, and Pharmacokinetics of a Single or Multiple Ascending Doses of CPX101Overweight and Obesity
NCT06545162Guangzhou Chia Tai Innovative Pharmaceutical Co., Ltd.72
Completed
Phase 1
MSC2364447C Phase 1b in Systemic Lupus ErythematosusLupus Erythematosus, Systemic
NCT02537028EMD Serono Research & Development Institute, Inc.24