A Multiple Dose Study of LY3502970 in Healthy Overweight and Obese Participants

Part of paid clinical trials in Daytona Beach, Florida.

Sponsor
Eli Lilly and Company
Study ID
NCT05841238
Phase
PHASE1
Status
Completed

Conditions

  • Healthy
  • Obese

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • LY3502970 — DRUG
    Administered orally.

Study Details

The main purpose of this study is to evaluate how much LY3502970 gets into the bloodstream and how long it takes the body to eliminate when administered orally as tablet and capsule formulations along with effect of food on LY3502970 in healthy overweight and obese participants. The study will also evaluate the safety and tolerability of LY3502970 in these participants. The study is conducted in two parts (part A and B) and will last up to 135 days including the screening period.

Key Dates

First listed
May 3, 2023
Start date
Apr 26, 2023
Status verified
Jun 2026
Primary completion
Sep 14, 2023
Completion
Nov 13, 2023

Study Design

Enrollment
52 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Part A: LY3502970 (Periods 1 to 11)
    Participants received a once daily (QD) oral dose of LY3502970 in the tablet or capsule formulation, depending on the period of the study, throughout Periods 1 to 11 as follows: * Period 1 (Day 1-7): 0.8 milligram (mg) LY3502970 tablet (fasted state) * Period 2 (Day 8-14): 2 mg LY3502970 capsule (fasted state) * Period 3 (Day 15-21): 2.5 mg LY3502970 tablet (fasted state) * Period 4 (Day 22-28): 5 mg LY3502970 tablet (fasted state) * Period 5 (Day 29-35): 8 mg LY3502970 capsule (fasted state) * Period 6 (Day 36-42): 10 mg LY3502970 tablet (fasted state) * Period 7 (Day 43-49): 16 mg LY3502970 capsule (fasted state) * Period 8 (Day 50-56): 20 mg LY3502970 tablet (fasted state) * Period 9 (Day 57-63): 36 mg LY3502970 capsule (fasted state) * Period 10 (Day 64-70): 36 mg LY3502970 capsule or 37.5 mg LY3502970 tablet (fed state) * Period 11 (Day 71-77): 37.5 mg LY3502970 tablet (fasted state)
  • Experimental: Part B: 45 mg LY3502970 / 60 mg LY3502970 (Periods 12 to 13)
    Participants after completion of Part A (Periods 1-11), in Part B received a QD oral dose of LY3502970 as follows: * Period 12 (Day 78-84): 45 mg LY3502970 tablet (fasted state) * Period 13 (Day 85-91): 60 mg LY3502970 tablet (fasted state)
  • Experimental: Part B: 35 mg LY3502970 / 35 mg LY3502970 (Periods 12 to 13)
    Participants after completion of Part A (Periods 1-11), in Part B received a QD oral dose of LY3502970 as follows: * Period 12 (Day 78-84): 35 mg LY3502970 tablet (fasted state) * Period 13 (Day 85-91): 35 mg LY3502970 tablet (fasted state)
  • Experimental: Part B: 36 mg LY3502970 DF / 36 mg LY3502970 EPB (Periods 12 to 13)
    Participants after completion of Part A (Periods 1-11), in Part B received a QD oral dose of LY3502970 as follows: * Period 12 (Day 78-84): 36 mg LY3502970 dual-fill (DF) capsule (fasted state) * Period 13 (Day 85-91): 36 mg LY3502970 extemporaneously prepared blended (EPB) capsule (fasted state)

Primary Outcome Measure

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13 [ Time Frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13 ]

Locations (3)

FacilityCityStateZIPSite coordinators
LabCorp CRU, Inc.Daytona BeachFlorida32117-
Labcorp Clinical Research LPDallasTexas75247-
LabCorp CRU, Inc.MadisonWisconsin53704-

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