A Multiple-Ascending Dose Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of LY3537031 in Overweight and Obese Participants and Healthy Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Eli Lilly and Company
- Enrollment
- 302
- Locations
- 4
- Primary Endpoint
- 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
Study Overview
Brief Summary
This is a 4-part study that includes a Part A, Part B, Part C, and Part D. Parts A and D 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 49 weeks excluding a screening period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 22 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Have a BMI within the range of:
- •Parts A and D: 27.0 to 45.0 kilogram per square meter (kg/m²)
- •Parts B and C: 22.0 to 26.9 kg/m²
- •Parts B and C: Weigh 60 kg (80 pounds (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), 10.2 picomoles per liter (pmol/L))
Arms & Interventions
LY3537031 Part A (Cohorts 1-7)
Multiple-ascending doses of LY3537031 administered subcutaneously (SC)
Intervention: LY3537031 (Drug)
Placebo Part A
Placebo administered SC
Intervention: Placebo (Drug)
LY3537031 Part B (Cohorts 8-11)
Multiple-ascending doses of LY3537031 administered SC
Intervention: LY3537031 (Drug)
Placebo Part B
Placebo administered SC
Intervention: Placebo (Drug)
LY3537031 Part C (Cohorts 12-15)
Multiple-ascending doses of LY3537031 administered SC
Intervention: LY3537031 (Drug)
Placebo Part C
Placebo administered SC
Intervention: Placebo (Drug)
LY3537031 Part D (Cohorts 16-19)
Multiple-ascending doses of LY3537031 administered SC
Intervention: LY3537031 (Drug)
Outcomes
Primary Outcomes
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
Time Frame: Baseline to Study Completion (Up to 56 Weeks)
A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module
Secondary Outcomes
- PK: Area Under the Concentration Versus Time Curve (AUC) of LY3537031(Predose on Day 1 through Week 56)
- Pharmacodynamic (PD): Change from Baseline in Body Weight(Baseline up to Week 56)
- PD: Change from Baseline in Fasting Glucose(Baseline up to Week 56)
- PD: Change from Baseline in Oral Glucose Tolerance Test (OGTT) Results(Baseline up to Week 56)
- PD: Change from Baseline in Insulin Levels(Baseline Up to Week 56)
- PD: Change from Baseline in Connecting Peptide (C-peptide) Levels(Baseline Up to Week 56)
- PD: Change from Baseline in Time to Peak Drug Concentration (Tmax) of Acetaminophen to Assess the Delay in Gastric Emptying(Baseline Up to Week 56)
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3537031(Predose on Day 1 through Week 56)
- PD: Change from Baseline in AUC of Glucose(Baseline Up to Week 56)
- PD: Change from Baseline in Cmax of Acetaminophen to Assess the Delay in Gastric Emptying(Baseline up to Week 56)
- PD: Change from Baseline in AUC of Acetaminophen to Assess the Delay in Gastric Emptying(Baseline Up to Week 56)