Clinical trial NCT06977880: A Phase 1, First-in-human Study of MORF-440 (LY4292009) in Healthy Participants
Official title: A Phase 1, First-in-human Study of MORF-440 in Healthy Participants, Including Single and Multiple Ascending Dose Cohorts
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2025-05-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)
timeFrame: Baseline to Study Completion (Up to Day 17)
measure: Percentage of Participants with TEAEs and SAEs in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)
timeFrame: Baseline to Study Completion (Up to Day 7)
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) in (Cohort A1-A6) and MAD (Cohort B1-B4)
timeFrame: Baseline to Study Completion (Up to Day 7)
measure: Change from Baseline in Laboratory Parameter and Vital Signs in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)
timeFrame: Baseline to Study Completion (Up to Day 7)
measure: Number of Participants with Clinically Significant Changes in Cardiovascular Evaluation in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)
timeFrame: Baseline to Study Completion (Up to Day 7)
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)
timeFrame: SAD Cohorts: Predose up to Day 4 Postdose
measure: PK: Time to Maximum Concentration (Tmax) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)
timeFrame: SAD Cohorts: Predose up to Day 4 Postdose
measure: PK: Area Under the Concentration Curve (AUC) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)
timeFrame: SAD Cohorts: Predose up to Day 4 Postdose
measure: PK: Time to Half Life (T1/2) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)
timeFrame: SAD Cohorts: Predose up to Day 4 Postdose
measure: PK: AUC From Time Zero to Infinity (AUC 0-inf) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)
timeFrame: SAD Cohorts: Predose up to Day 4 Postdose
measure: PK: CL/F in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)
timeFrame: SAD Cohorts: Predose up to Day 4 Postdose
measure: PK: Vd/F in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)
timeFrame: SAD Cohorts: Predose up to Day 4 Postdose
measure: PK: Urine: Ae(total) in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)
timeFrame: SAD Cohorts: Predose up to Day 4 Postdose
measure: PK: CLR in SAD (Cohort A1-A6) and MAD (Cohort B1-B4)
timeFrame: SAD Cohorts: Predose up to Day 4 Postdose
Other outcomes:
Locations:
city: Mont-royal
country: Canada
facility: Altasciences Company Inc.
state: Quebec
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: