Clinical trial NCT06557356: A Study of LY3532226 in Participants With Obesity
Official title: A Dose-Escalation Phase 1, Investigator- and Participant-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of LY3532226 in Participants With Obesity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-08-16
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Part A: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline to Study Completion (Up to 16 Weeks)
measure: Part B: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline to Study Completion (Up to 20 Weeks)
Secondary outcomes:
measure: Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3532226
timeFrame: Predose on Day 1 through Week 16
measure: Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3532226
timeFrame: Predose on Day 1 through Week 16
measure: Part B: PK: Cmax of LY3532226
timeFrame: Predose on Day 1 through Week 20
measure: Part B: PK: AUC of LY3532226
timeFrame: Predose on Day 1 through Week 20
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Fortrea Clinical Research Unit
state: Florida
city: Dallas
country: United States
facility: Fortrea Clinical Research Unit
state: Texas
city: Madison
country: United States
facility: Fortrea Clinical Research Unit
state: Wisconsin
city: Singapore
country: Singapore
facility: Lilly Centre for Clinical Pharmacology
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: