A Study of LY4268989 (MORF-057) in Healthy Participants

Part of paid clinical trials in Anaheim, California.

Sponsor
Eli Lilly and Company
Study ID
NCT06964776
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • LY4268989 — DRUG
    Administered orally
  • Placebo — DRUG
    Administered placebo
  • Midazolam — DRUG
    Administered orally
  • Midazolam — DRUG
    Administered intravenously (IV)

Study Details

The purpose of this study is to measure the body's absorption and processing of the study drug, the study drug's effect on the body, safety, and tolerability with LY4268989 (MORF-57) in healthy participants, including Japanese and Chinese participants

Key Dates

Start date
May 1, 2025
Status verified
Mar 2026
Primary completion
Feb 17, 2026
Completion
Feb 17, 2026

Study Design

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

Arms

  • Experimental: LY4268989 or Placebo Cohort 1 (Blinded)
    Participants will receive LY4268989 orally or placebo single dose followed by BID administration
  • Experimental: LY4268989 Cohort 2 (Open-Label)
    Participants will receive LY4268989 orally tablet (formulation compared to capsule formulation) in a fasted state
  • Experimental: LY4268989 Cohort 3 (Open-Label)
    Participants will receive multiple doses of LY4268989 orally BID administration with midazolam orally and intravenously (IV).
  • Experimental: LY4268989 or Placebo Cohort 4 (Blinded)
    Participants will receive single escalating doses of LY4268989 orally or placebo
  • Experimental: LY4268989 Cohort 5 (Blinded)
    Participants will receive multiple doses of LY4268989 orally or placebo
  • Experimental: LY4268989 Cohort 6 (Open-Label)
    Participants will receive LY4268989 single dose orally in a fasted and fed state
  • Experimental: LY4268989 Cohort 7 (Open-Label)
    Participants will receive multiple doses of LY4268989 orally BID administration in a fed state
  • Experimental: LY4268989 Cohort 8 (Open-Label)
    Participants will receive multiple doses of LY4268989 orally BID administration with midazolam IV in a fasted state.

Primary Outcome Measure

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4268989 (Cohort 1) and (Cohort 5) [ Time Frame: Day 1 to Day 17 ]

Locations (1)

FacilityCityStateZIPSite coordinators
CenExel ACTAnaheimCalifornia92801-

Find similar trials in Anaheim, CA

By research site
CenExel ACT· Anaheim, CA

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