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J1I-MC-GZBW TRIPLE G: 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

NCTPending

TRIPLE G: 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

Principal Investigator

Sponsor

Eli Lilly

Study Purpose: The purposes of this study are to look at the effect of the study drug compared to placebo (a drug that looks like the study drug but has no active medicine) on calorie intake, different uses of energy in the body, and appetite.

To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if
you meet the following criteria:

Study Duration: Up to 26 weeks

Study Commitment: 1 screening visit (approximately 3-4 hours), up to15 outpatient visits, two 5-Day inpatient visits, two 3-day inpatient visits

Age: 18 to 60 years old

Sex: Male and Female

Conditions/Eligibility: BMI>30.0 kg/m2
A history of at least 1 self-reported unsuccessful dietary effort to reduce body weight.
Weight stable (change of less than 5kg (11 pounds) over past 3 months.
Have not had any of the following treatments for obesity within 1 year prior, or plan to undergo any of these during the study period:

ear prior, or plan to undergo any of these during the study period:
□ liposuction
□ cryolipolysis, or
□ abdominoplasty.
No prior or planned weight loss procedure such as bariatric surgery, endoscopic therapy, or device-based therapy (unless removed 6-months prior).
Does NOT have diabetes.

Study Procedures:
Vital Signs, ECG, weight, height, and BMI
Physical Examination
Dietary Counseling
Multiple questionnaires
Body Composition Testing
Study medication
Activity Monitor

Compensation: Up to $15,000

This study is currently enrolling.