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Completed

NCT Number: NCT06977880

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences Company Inc.

Mount Royal, H3p 3p1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY4292009

Drug

Administered orally

Placebo

Drug

Administered orally.

Primary outcomes

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

    Time frame: Baseline to Study Completion (Up to Day 17)

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

    Time frame: Baseline to Study Completion (Up to Day 7)

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

    Time frame: Baseline to Study Completion (Up to Day 7)

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

    Time frame: Baseline to Study Completion (Up to Day 7)

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

    Time frame: Baseline to Study Completion (Up to Day 7)

Secondary outcomes

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

    Time frame: SAD Cohorts: Predose up to Day 4 Postdose

    Maximum observed plasma concentration

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

    Time frame: SAD Cohorts: Predose up to Day 4 Postdose

    Time to reach Cmax, defined as the first point if multiple maximum values occur.

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

    Time frame: SAD Cohorts: Predose up to Day 4 Postdose

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

    Time frame: SAD Cohorts: Predose up to Day 4 Postdose

    Apparent first-order terminal phase half-life, calculated as 0.693/λ

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

    Time frame: SAD Cohorts: Predose up to Day 4 Postdose

    Area under the concentration-time curve from time 0 extrapolated to infinity. Calculated as the sum of AUC0-t plus the ratio of the last measurable concentration to the terminal phase rate constant (λz).

  6. PK: CL/F in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)

    Time frame: SAD Cohorts: Predose up to Day 4 Postdose

    Apparent total clearance after oral administration, calculated as Dose/AUC0-inf

  7. PK: Vd/F in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)

    Time frame: SAD Cohorts: Predose up to Day 4 Postdose

    Apparent volume of distribution during terminal phase after oral administration, calculated as Dose/[λz*AUC0-inf]

  8. PK: Urine: Ae(total) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)

    Time frame: SAD Cohorts: Predose up to Day 4 Postdose

    otal amount of urinary excretion (cohorts participating in urinary PK sample collection only)

  9. PK: CLR in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)

    Time frame: SAD Cohorts: Predose up to Day 4 Postdose

    Clearance of urinary excretion (cohorts participating in urinary PK sample collection only), calculated as Ae/AUC0-inf

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

A Phase 1, First-in-human Study of MORF-440 in Healthy Participants, Including Single and Multiple Ascending Dose Cohorts

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 18, 2025
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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