Clinical trial NCT06313528: A Study to Measure Calorie Consumption and Usage in Participants With Obesity Using LY3437943
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Obesity
Keywords: Food
Diet
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-03-15
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Total Calorie Intake at Lunch and Dinner (Combined)
timeFrame: Baseline up to Week 17 (inclusive)
Secondary outcomes:
measure: Change from Baseline in Sleep Metabolic Rate (SMR)
timeFrame: Baseline up to Week 16 (inclusive)
measure: Change from Baseline in SMR
timeFrame: Baseline up to Week 16 (inclusive)
measure: Change from Baseline in 24-hour Energy Expenditure (EE)
timeFrame: Baseline up to Week 16 (inclusive)
measure: Change from Baseline in 24-hour EE
timeFrame: Baseline up to Week 16 (inclusive)
measure: Change from Baseline in Total Calorie Intake at Lunch
timeFrame: Baseline up to Week 17 (inclusive)
measure: Change from Baseline in Total Calorie Intake at Dinner
timeFrame: Baseline up to Week 17 (inclusive)
measure: Change from Baseline in Fasting Appetite Visual Analog Score (VAS)
timeFrame: Baseline up to Week 16 (inclusive)
Other outcomes:
Locations:
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: