A Study to Compare Tablets and Capsules of Orforglipron (LY3502970) in Healthy Participants Who Are Obese or Overweight

Part of paid clinical trials in Anaheim, California.

Sponsor
Eli Lilly and Company
Study ID
NCT06440980
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The main purpose of this study is to see how much of orforglipron (study drug) gets into the bloodstream and how long it takes the body to get rid of it when given as capsules compared to tablets in healthy overweight and obese participants. The safety and tolerability (side effects) of orforglipron when given as capsules and tablets will also be evaluated. The study will be conducted in two parts, with part A and B lasting up to approximately 25 and 22 weeks each respectively, including the screening period.

Key Dates

Start date
Jun 24, 2024
Status verified
Jun 2025
Primary completion
Jun 2, 2025
Completion
Jun 2, 2025

Study Design

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

Arms

  • Experimental: Part A: Relative bioavailability study: Cohort 1 and 2: Orforglipron
    Participants will receive different sequences of orforglipron doses administered as either tablet or capsule at different dose levels.
  • Experimental: Part B: BE (bioequivalence) study: Cohort 1 and 2: Orforglipron
    Participants will receive different sequences of orforglipron doses administered as either tablet (different dose levels) or capsule (test dose levels 1 to 6).

Primary Outcome Measure

Part B: Pharmacokinetics (PK): Steady-state area under the concentration versus time curve from time 0 to τ hour time point AUC(0-τ) of Orforglipron capsule at test dose levels 2,3,4 and 6 along with the corresponding tablet dose strengths [ Time Frame: Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2) ]

Locations (7)

FacilityCityStateZIPSite coordinators
Anaheim Clinical Trials, LLCAnaheimCalifornia92801-
Collaborative Neuroscience Research, LLCLos AlamitosCalifornia90720-
Fortrea Clinical Research UnitDaytona BeachFlorida32117-
Altasciences Company Inc.Overland ParkKansas66212-
QPSSpringfieldMissouri65802-
Fortrea Clinical Research UnitDallasTexas75247-
Fortrea Clinical Research UnitMadisonWisconsin53704-

Find similar trials in Anaheim, CA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Anaheim Clinical Trials, LLC· Anaheim, CACollaborative Neuroscience Research, LLC· Los Alamitos, CAFortrea Clinical Research Unit· Daytona Beach, FLAltasciences Company Inc.· Overland Park, KSQPS· Springfield, MOFortrea Clinical Research Unit· Dallas, TX

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