A Study to Measure Calorie Consumption and Usage in Participants With Obesity Using LY3437943

Lilly

Status and phase: Active, not recruiting; Phase 1

Conditions: Obesity

Treatments: Other: Placebo; Drug: LY3437943

Study type: Interventional

Funder types: Industry

Identifiers

NCT06313528

18726

J1I-MC-GZBW (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 2 patient groups, including a placebo group

LY3437943

Experimental group

Description:

LY3437943 administered subcutaneously (SC)

Treatment:

Drug: LY3437943

Placebo

Placebo Comparator group

Description:

Placebo administered SC

Treatment:

Other: Placebo