Obesity
Conditions
Keywords
Food, Diet
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.
Interventions
DRUGLY3437943
Administered SC
OTHERPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Sponsor-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Total Calorie Intake at Lunch and Dinner (Combined) | Baseline up to Week 17 (inclusive) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | In participants who achieve target weight loss |
| Change from Baseline in 24-hour EE | Baseline up to Week 16 (inclusive) | — |
| Change from Baseline in Sleep Metabolic Rate (SMR) | Baseline up to Week 16 (inclusive) | In participants who achieve target weight loss |
| 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) | — |
| Change from Baseline in Total Calorie Intake at Lunch | Baseline up to Week 17 (inclusive) | — |
Countries
United States
Outcome results
None listed