A Study of LY3971297 in Healthy Participants

Part of paid clinical trials in Anaheim, California.

Sponsor
Eli Lilly and Company
Study ID
NCT06148272
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to measure side effects of LY3971297 injection administered under the skin in healthy participants and obese participants with high blood pressure (BP). Blood tests will be performed to check how much LY3971297 gets into the bloodstream and how long it takes the body to eliminate it. This is a 7-part study. The study duration will be approximately 60 days for Parts A and F, and approximately 90 days for Parts B, C, D, E, and G.

Key Dates

Start date
Dec 7, 2023
Status verified
Apr 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
225 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: LY3971297 (Part A)
    Single ascending doses of LY3971297 administered subcutaneously (SC) in healthy participants
  • Experimental: LY3971297 (Part B)
    Multiple ascending doses of LY3971297 administered SC in healthy participants
  • Experimental: LY3971297 (Part C)
    Multiple ascending doses of LY3971297 administered SC in healthy Chinese participants
  • Experimental: LY3971297 (Part D)
    Multiple ascending doses of LY3971297 administered SC
  • Experimental: LY3971297 (Part E)
    Multiple doses of LY3971297 administered SC in healthy Japanese participants
  • Placebo Comparator: Placebo (Part A, B, C, D, E, & G)
    Placebo administered SC
  • Experimental: LY3971297 (Part F)
    Single doses of LY3971297 administered intravenously (IV) in healthy participants
  • Experimental: LY3971297 (Part G)
    Multiple doses of LY3971297 administered SC

Primary Outcome Measure

Part A and F: 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 [ Time Frame: Baseline (Day of Exposure) to Day 29 post-dose ]

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (3)

FacilityCityStateZIPSite coordinators
CenExel ACTAnaheimCalifornia92801
714-774-7777
Amina Haggag (PRINCIPAL_INVESTIGATOR)
Clinical Pharmacology of MiamiMiamiFlorida33172
305-817-2900
Angel Lamas (PRINCIPAL_INVESTIGATOR)
ICON Early Phase ServicesSan AntonioTexas78209
210-283-4500
Cassandra Key (PRINCIPAL_INVESTIGATOR)

Find similar trials in Anaheim, CA

By condition
Hypertension (high blood pressure)Obesity / overweight
By specialty
CardiologyHeart diseaseEndocrinologyMetabolic healthWeight loss
By research site
CenExel ACT· Anaheim, CAClinical Pharmacology of Miami· Miami, FLICON Early Phase Services· San Antonio, TX

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