A Phase 1, First-in-human Study of MORF-440 (LY4292009) in Healthy Participants

NCT06977880 | Completed Phase 1

• 3 other identifiers: 27728Morf-440-101J6O-MC-UMAA
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of single ascending doses of MORF-440 administered to healthy participants single-ascending dose (SAD) and maximum ascending dose (MAD) substudy.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)

  Baseline to Study Completion (Up to Day 17)

• Percentage of Participants with TEAEs and SAEs in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)

  Baseline to Study Completion (Up to Day 7)

• Number of Participants with One or More Serious Adverse Event(s) (SAEs) in (Cohort A1-A6) and MAD (Cohort B1-B4)

  Baseline to Study Completion (Up to Day 7)

• Change from Baseline in Laboratory Parameter and Vital Signs in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)

  Baseline to Study Completion (Up to Day 7)

• Number of Participants with Clinically Significant Changes in Cardiovascular Evaluation in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)

  Baseline to Study Completion (Up to Day 7)

Secondary Outcomes (9)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)

  SAD Cohorts: Predose up to Day 4 Postdose

• PK: Time to Maximum Concentration (Tmax) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)

  SAD Cohorts: Predose up to Day 4 Postdose

• PK: Area Under the Concentration Curve (AUC) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)

  SAD Cohorts: Predose up to Day 4 Postdose

• PK: Time to Half Life (T1/2) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)

  SAD Cohorts: Predose up to Day 4 Postdose

• PK: AUC From Time Zero to Infinity (AUC 0-inf) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)

  SAD Cohorts: Predose up to Day 4 Postdose

Study Arms (11)

Cohort A1

EXPERIMENTAL

Participants received LY4292009 orally.

Drug: LY4292009

Cohort A2

EXPERIMENTAL

Participants received LY4292009 orally.

Drug: LY4292009

Cohort A3

EXPERIMENTAL

Participants received LY4292009 orally.

Drug: LY4292009

Cohort A4

EXPERIMENTAL

Participants received LY4292009 orally.

Drug: LY4292009

Cohort A5

EXPERIMENTAL

Participants received LY4292009 orally.

Drug: LY4292009

Cohort A6 (Optional)

EXPERIMENTAL

Participants received LY4292009 orally.

Drug: LY4292009

Cohort B1

EXPERIMENTAL

Participants received LY4292009 orally.

Drug: LY4292009

Cohort B2

EXPERIMENTAL

Participants received LY4292009 orally.

Drug: LY4292009

Cohort B3

EXPERIMENTAL

Participants received LY4292009 orally.

Drug: LY4292009

Cohort B4 (Optional)

EXPERIMENTAL

Participants received LY4292009 orally.

Drug: LY4292009

Placebo

PLACEBO COMPARATOR

Participants receive placebo.

Drug: Placebo

Interventions

LY4292009 DRUG

Administered orally

Cohort A1; Cohort A2; Cohort A3; Cohort A4; Cohort A5; Cohort A6 (Optional); Cohort B1; Cohort B2; Cohort B3; Cohort B4 (Optional)

Placebo DRUG

Administered orally.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index (BMI) within 18.0 kg/m² to 30.0 kg/m², inclusive
• If male, meets one of the following:
• can procreate and agree to use one of the accepted to use one of the accepted contraceptive regimens and not to donate sperm from the first study drug administration to at least 90 days after the last drug administration.
• is unable to procreate; defined as surgically sterile (i.e., has undergone a vasectomy at least 180 days prior to the first study drug administration)
• if female, meets one of the following:
• is of childbearing potential and agrees to use an acceptable contraceptive method.
• is of non-childbearing potential, defined as either:
• Surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or
• is in a postmenopausal state:
• At least 1 year without menses and without an alternative medical condition prior to the screening, and follicle stimulating hormone (FSH) levels ≥ 40 mIU/mL at screening or at least 1 year without menses and without an alternative medical condition prior to the screening, follicle stimulating hormone FSH levels \< 40 milli-international units per milliliter (mIU/mL) and estradiol serum level ≤150 picomole/Liter (pmol/L) at screening

You may not qualify if:

• Female who is lactating or who is pregnant according to the pregnancy test at screening or prior to the first study drug administration, or planning to become pregnant during the study period up to 30 days after the last study drug administration
• Nicotine intake (e.g., smoking, nicotine patch, nicotine chewing gum, chewing tobacco, electronic cigarettes) within 1 month before screening and/or inability to refrain from nicotine from screening until the end of the study

Sponsors & Collaborators

• Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company): lead

Study Sites (1)

Altasciences Company Inc.

Mount Royal, H3p 3p1, Canada

Location

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 18, 2025
• Study Start: February 19, 2025
• Primary Completion: March 20, 2026
• Study Completion: March 20, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)