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HealthyPhase 1NCT06977880

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

A Phase 1 study testing LY4292009 in people with Healthy, run by Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company) at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
LY4292009
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteCanada
Study dates
19 Feb 2025to 20 Mar 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Altasciences Company Inc.

    Mount Royal, H3p 3p1

Other trials in Canada

About this study

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

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
Being tested
LY4292009, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY4292009Drug

    Administered orally

  • PlaceboDrug

    Administered orally.

Study groups in NCT06977880
Study groupRoleWhat they receive
Cohort A1ExperimentalParticipants received LY4292009 orally.
Receives: Drug: LY4292009
Cohort A2ExperimentalParticipants received LY4292009 orally.
Receives: Drug: LY4292009
Cohort A3ExperimentalParticipants received LY4292009 orally.
Receives: Drug: LY4292009
Cohort A4ExperimentalParticipants received LY4292009 orally.
Receives: Drug: LY4292009
Cohort A5ExperimentalParticipants received LY4292009 orally.
Receives: Drug: LY4292009
Cohort A6 (Optional)ExperimentalParticipants received LY4292009 orally.
Receives: Drug: LY4292009
Cohort B1ExperimentalParticipants received LY4292009 orally.
Receives: Drug: LY4292009
Cohort B2ExperimentalParticipants received LY4292009 orally.
Receives: Drug: LY4292009
Cohort B3ExperimentalParticipants received LY4292009 orally.
Receives: Drug: LY4292009
Cohort B4 (Optional)ExperimentalParticipants received LY4292009 orally.
Receives: Drug: LY4292009
PlaceboPlacebo comparatorParticipants receive placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: Baseline to Study Completion (Up to Day 7)

Secondary outcomes (9)

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

    Maximum observed plasma concentration

    Measured: SAD Cohorts: Predose up to Day 4 Postdose

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

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

    Measured: SAD Cohorts: Predose up to Day 4 Postdose

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

    Measured: 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)

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

    Measured: SAD Cohorts: Predose up to Day 4 Postdose

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

    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).

    Measured: SAD Cohorts: Predose up to Day 4 Postdose

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

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

    Measured: SAD Cohorts: Predose up to Day 4 Postdose

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

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

    Measured: SAD Cohorts: Predose up to Day 4 Postdose

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

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

    Measured: SAD Cohorts: Predose up to Day 4 Postdose

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

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

    Measured: SAD Cohorts: Predose up to Day 4 Postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2025
  2. Study start19 Feb 2025
  3. Primary completion20 Mar 2026
  4. Study completion20 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06977880
Sponsor's protocol ID
27728
Other IDs
Morf-440-101, J6O-MC-UMAA
Status last verified
Apr 2026
First submitted
12 May 2025
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY4292009 in people with Healthy, run by Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company) at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: Baseline to Study Completion (Up to Day 17)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06977880.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.

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