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

NCT ID: NCT06977880

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-19

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Cohort A1

Participants received LY4292009 orally.

Group Type EXPERIMENTAL

LY4292009

Intervention Type DRUG

Administered orally

Cohort A2

Participants received LY4292009 orally.

Group Type EXPERIMENTAL

LY4292009

Intervention Type DRUG

Administered orally

Cohort A3

Participants received LY4292009 orally.

Group Type EXPERIMENTAL

LY4292009

Intervention Type DRUG

Administered orally

Cohort A4

Participants received LY4292009 orally.

Group Type EXPERIMENTAL

LY4292009

Intervention Type DRUG

Administered orally

Cohort A5

Participants received LY4292009 orally.

Group Type EXPERIMENTAL

LY4292009

Intervention Type DRUG

Administered orally

Cohort A6 (Optional)

Participants received LY4292009 orally.

Group Type EXPERIMENTAL

LY4292009

Intervention Type DRUG

Administered orally

Cohort B1

Participants received LY4292009 orally.

Group Type EXPERIMENTAL

LY4292009

Intervention Type DRUG

Administered orally

Cohort B2

Participants received LY4292009 orally.

Group Type EXPERIMENTAL

LY4292009

Intervention Type DRUG

Administered orally

Cohort B3

Participants received LY4292009 orally.

Group Type EXPERIMENTAL

LY4292009

Intervention Type DRUG

Administered orally

Cohort B4 (Optional)

Participants received LY4292009 orally.

Group Type EXPERIMENTAL

LY4292009

Intervention Type DRUG

Administered orally

Placebo

Participants receive placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally.

Interventions

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LY4292009

Administered orally

Intervention Type DRUG

Placebo

Administered orally.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Altasciences Company Inc.

Mount Royal, , Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Role: CONTACT

1-317-615-4559

Physicians interested in becoming principal investigators please contact

Role: CONTACT

Facility Contacts

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Role: primary

450-973-3155 x 113202

Other Identifiers

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Morf-440-101

Identifier Type: OTHER

Identifier Source: secondary_id

J6O-MC-UMAA

Identifier Type: OTHER

Identifier Source: secondary_id

27728

Identifier Type: -

Identifier Source: org_study_id

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