Clinical trial NCT06606106: A Study of LY3537031 in Overweight, Obese, and Healthy Participants
Official title: A Multiple-Ascending Dose Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of LY3537031 in Overweight and Obese Participants and Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Obesity
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-09-20
Enrollment: 230
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a 3-part study that includes a Part A, Part B, and Part C. Part A will study the safety and tolerability of the study drug known as LY3537031 in participants who are overweight and obese. Part B and Part C will study the safety and tolerability of LY3537031 in healthy participants. Part C will contain only Japanese and Chinese healthy participants.

Blood tests will be performed to check how much LY3537031 gets into the bloodstream and how long it takes the body to eliminate it. Body weight will be measured. The study will last approximately 48 weeks excluding a screening period.


Eligibility criteria: Inclusion Criteria:

* Have a BMI within the range of:

  * Part A: 27.0 to 45.0 kilogram per square meter (kg/m²)
  * Part B: 22.0 to 26.9 kg/m²
* Parts B and C: Weigh 60 kg (80 lbs) or more at screening
* Have no significant (not more than 5%) self-reported weight gain or loss in the past 3 months prior to screening
* Have a thyroid stimulating hormone (TSH) value within normal local laboratory ranges.

Exclusion Criteria:

* Have undergone any form of bariatric surgery
* Participants who are lactating
* Have taken medications that promote weight loss within 90 days before screening
* Have a serum calcitonin level (at screening) of greater than or equal to 35 nanograms per liter (ng/L) (35 picograms per milliliter (pg/mL))

Primary outcomes:
measure: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline to Study Completion (Up to 56 Weeks)
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3537031
timeFrame: Predose on Day 1 through Week 56
measure: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3537031
timeFrame: Predose on Day 1 through Week 56
measure: Pharmacodynamic (PD): Change from Baseline in Body Weight
timeFrame: Baseline up to Week 56
measure: PD: Change from Baseline in Fasting Glucose
timeFrame: Baseline up to Week 56
measure: PD: Change from Baseline in Oral Glucose Tolerance Test (OGTT) Results
timeFrame: Baseline up to Week 56
measure: PD: Change from Baseline in AUC of Glucose
timeFrame: Baseline Up to Week 56
measure: PD: Change from Baseline in Insulin Levels
timeFrame: Baseline Up to Week 56
measure: PD: Change from Baseline in Connecting Peptide (C-peptide) Levels
timeFrame: Baseline Up to Week 56
measure: PD: Change from Baseline in Cmax of Acetaminophen to Assess the Delay in Gastric Emptying
timeFrame: Baseline up to Week 56
measure: PD: Change from Baseline in AUC of Acetaminophen to Assess the Delay in Gastric Emptying
timeFrame: Baseline Up to Week 56
measure: PD: Change from Baseline in Time to Peak Drug Concentration (Tmax) of Acetaminophen to Assess the Delay in Gastric Emptying
timeFrame: Baseline Up to Week 56
Other outcomes:
Locations:
city: Los Alamitos
country: United States
facility: Collaborative Neuroscience Research, LLC
state: California
city: Daytona Beach
country: United States
facility: Fortrea Clinical Research Unit
state: Florida
city: Miami
country: United States
facility: Clinical Pharmacology of Miami
state: Florida
city: Springfield
country: United States
facility: QPS
state: Missouri
city: Dallas
country: United States
facility: Fortrea Clinical Research Unit
state: Texas
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: