A Study of LY3532226 in Participants With Obesity

Lilly

Status and phase: Active, not recruiting; Phase 1

Conditions: Obesity

Treatments: Drug: Placebo; Drug: LY3532226

Study type: Interventional

Funder types: Industry

Identifiers

NCT06557356

J2V-MC-GZLD (Other Identifier)

18835

Details and patient eligibility

About

The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3532226 in participants with obesity. Blood tests will be performed to check how much LY3532226 gets into the bloodstream and how long it takes the body to eliminate it following weekly or monthly administration. Part A of the study will last approximately 16 weeks, excluding screening period. Part B of the study will last approximately 20 weeks, excluding the screening period. Part C of the study will last approximately 8 weeks, excluding the screening period.

Enrollment: 129 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a body weight not exceeding 150 kilograms (kg) or 330 pounds (lb) and body mass index (BMI) within the range of 30 to 40 kilogram per square meter (kg/m²)
• Have had a stable body weight that is less than or equal to 5% change in body weight for 3 months prior to screening and enrollment

Exclusion criteria

• Have a lifetime history of a suicide attempt
• Have a history or presence of psychiatric disorders, including a history of major depressive disorder within the last 2 years
• Have a baseline Patient Health Questionnaire-9 (PHQ-9) score of 15 or greater, and/or a score of 2 or greater for either of the first 2 questions on the PHQ-9 questionnaire
• Have a known clinically significant gastric emptying abnormality, have undergone gastric bypass surgery or restrictive bariatric surgery
• Have taken approved or investigational medication for weight loss, within the previous 3 months or 5 half-lives of study screening, whichever is earlier
• Intend to use any weight-loss medications during study participation
• Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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129 participants in 6 patient groups, including a placebo group

LY3532226 (Part A)

Experimental group

Description:

LY3532226 administered subcutaneously (SC)

Treatment:

Drug: LY3532226

Placebo (Part A)

Placebo Comparator group

Description:

Placebo administered SC

Treatment:

Drug: Placebo

LY3532226 (Part B)

Experimental group

Description:

LY3532226 administered SC

Treatment:

Drug: LY3532226

Placebo (Part B)

Placebo Comparator group

Description:

Placebo administered SC

Treatment:

Drug: Placebo

LY3532226 (Part C)

Experimental group

Description:

LY3532226 administered SC

Treatment:

Drug: LY3532226

Placebo (Part C)

Placebo Comparator group

Description:

Placebo administered SC

Treatment:

Drug: Placebo