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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06313528
Other study ID # 18726
Secondary ID J1I-MC-GZBW
Status Recruiting
Phase Phase 1
First received
Last updated
Start date March 20, 2024
Est. completion date July 2025

Study information

Verified date April 2024
Source Eli Lilly and Company
Contact There may be multiple sites in this clinical trial. 1-877-CTLILL
Phone 1-317-615-4559
Email ClinicalTrials.gov@lilly.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 74
Est. completion date July 2025
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
LY3437943
Administered SC
Other:
Placebo
Administered SC

Locations

Country Name City State
United States Pennington Biomedical Research Center Baton Rouge Louisiana
United States Columbia University Medical Center New York New York
United States AdventHealth Orlando Orlando Florida

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in Total Calorie Intake at Lunch and Dinner (Combined) Baseline up to Week 17 (inclusive)
Secondary Change from Baseline in Sleep Metabolic Rate (SMR) In participants who achieve target weight loss Baseline up to Week 16 (inclusive)
Secondary Change from Baseline in SMR Baseline up to Week 16 (inclusive)
Secondary Change from Baseline in 24-hour Energy Expenditure (EE) In participants who achieve target weight loss Baseline up to Week 16 (inclusive)
Secondary Change from Baseline in 24-hour EE Baseline up to Week 16 (inclusive)
Secondary Change from Baseline in Total Calorie Intake at Lunch Baseline up to Week 17 (inclusive)
Secondary Change from Baseline in Total Calorie Intake at Dinner Baseline up to Week 17 (inclusive)
Secondary Change from Baseline in Fasting Appetite Visual Analog Score (VAS) Baseline up to Week 16 (inclusive)
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