Healthy VolunteersPhase 1NCT04580745
Study of MORF 057 to Evaluate Single and Multi Ascending Doses in Healthy Volunteers
A Phase 1 study testing MORF-057 in people with Healthy Volunteers, run by Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company) at 1 site in United States.
Trial summary
Phase 1a randomized, double-blind, placebo-controlled study to evaluate single and multiple ascending doses of MORF-057 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- MORF-057
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2020to 12 Apr 2021
- 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
- Healthy male and female subjects between 18 to 65 years old with a body mass index between 18 and 32 kg/m2
- Determined to be medically healthy by the Investigator.
- Use of acceptable methods of contraceptives.
- Ability to provide written informed consent and to understand and comply with the requirements of the study.
Who cannot join
- History of any malignancy, except basal or squamous cell carcinoma of the skin that resolved or in remission prior to Screening.
- Abnormal laboratory values at Screening.
- Any clinically significant major diseases.
- Female who is pregnant or breastfeeding, or planning to become pregnant during the course of the study.
- Unwilling or unable to comply with the requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1a Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Oral MORF-057 in Healthy Subjects
Phase 1a randomized, double-blind, placebo-controlled study to evaluate single and multiple ascending doses of MORF-057 in healthy subjects.
- Conditions
- Healthy Volunteers
- Being tested
- MORF-057, Placebo for MORF-057
- Keywords
- MORF-057
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MORF-057Drug
SAD: Subjects will be assigned to one of five planned dose cohorts and receive single doses of MORF-057.
Food Effect: Subjects will receive single dose administration of MORF-057 in fed and fasted states.
MAD: Subjects will be assigned to one of three planned dose cohorts and receive multiple doses of MORF-057.
Placebo for MORF-057Drug
SAD: Subjects will be assigned to one of five planned dose cohorts and receive single doses of placebo.
MAD: Subjects will be assigned to one of three planned dose cohorts and receive multiple doses of placebo.
| Study group | Role | What they receive |
|---|---|---|
| MORF-057 | Experimental | SAD: Subjects will be assigned to one of five planned dose cohorts and receive single doses of MORF-057.
Food Effect: Subjects will receive single dose administration of MORF-057 in fed and fasted states.
MAD: Subjects will be assigned to one of three planned dose cohorts and receive multiple doses of MORF-057. Receives: Drug: MORF-057 |
| Placebo for MORF-057 | Experimental | SAD: Subjects will be assigned to one of five planned dose cohorts and receive single doses of placebo.
MAD: Subjects will be assigned to one of three planned dose cohorts and receive multiple doses of placebo. Receives: Drug: Placebo for MORF-057 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events and safety signals observed during single and multiple ascending doses of MORF-057 administered orally to healthy adult subjects
Subject incidence of adverse events and serious adverse events
Measured: Day -1 to Day 28
Maximum Plasma Concentration (Cmax) of MORF-057 in a fed state
Cmax (Food Effect cohort)
Measured: Day -1 to Day 28
Time to Reach Cmax (Tmax) of MORF-057 in a fed state
Tmax (Food Effect cohort)
Measured: Day -1 to Day 28
Secondary outcomes (3)
Maximum Plasma Concentration (Cmax) during single and multiple ascending doses of MORF-057
Cmax of MORF-057
Measured: Day -1 to Day 28
Time to Reach Cmax (Tmax) during single and multiple ascending doses of MORF-057
Tmax of MORF-057
Measured: Day -1 to Day 28
Incidence of adverse events and safety signals observed during single dose of MORF-057 administered after a meal to healthy subjects.
Subject incidence of adverse events and serious adverse events.
Measured: Day -1 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start23 Sep 2020
- Primary completion31 Mar 2021
- Study completion12 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580745
- Sponsor's protocol ID
- 27496
- Other IDs
- J6E-MC-KWAE, MORF-057-101
- Status last verified
- Jul 2025
- First submitted
- 16 Sep 2020
- Last updated
- 1 Aug 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Oral MORF-057 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04580745
- Acronym / sponsor ID
- 27496
- Conditions
- Healthy Volunteers
- Keywords
- MORF-057
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 1a randomized, double-blind, placebo-controlled study to evaluate single and multiple ascending doses of MORF-057 in healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MORF-057 | Experimental | Drug: MORF-057SAD: Subjects will be assigned to one of five planned dose cohorts and receive single doses of MORF-057. Food Effect: Subjects will receive single dose administration of MORF-057 in fed and fasted states. MAD: Subjects will be assigned to one of three planned dose cohorts and receive multiple doses of MORF-057. |
| Placebo for MORF-057 | Experimental | Drug: Placebo for MORF-057SAD: Subjects will be assigned to one of five planned dose cohorts and receive single doses of placebo. MAD: Subjects will be assigned to one of three planned dose cohorts and receive multiple doses of placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male and female subjects between 18 to 65 years old with a body mass index between 18 and 32 kg/m2
- Determined to be medically healthy by the Investigator.
- Use of acceptable methods of contraceptives.
- Ability to provide written informed consent and to understand and comply with the requirements of the study.
Key exclusion criteria (5 listed)
- History of any malignancy, except basal or squamous cell carcinoma of the skin that resolved or in remission prior to Screening.
- Abnormal laboratory values at Screening.
- Any clinically significant major diseases.
- Female who is pregnant or breastfeeding, or planning to become pregnant during the course of the study.
- Unwilling or unable to comply with the requirements of the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MORF-057SAD: Subjects will be assigned to one of five planned dose cohorts and receive single doses of MORF-057. Food Effect: Subjects will receive single dose administration of MORF-057 in fed and fasted states. MAD: Subjects will be assigned to one of three planned dose cohorts and receive multiple doses of MORF-057. | Drug | MORF-057 |
| Placebo for MORF-057SAD: Subjects will be assigned to one of five planned dose cohorts and receive single doses of placebo. MAD: Subjects will be assigned to one of three planned dose cohorts and receive multiple doses of placebo. | Drug | Placebo for MORF-057 |
Primary outcome
Incidence of adverse events and safety signals observed during single and multiple ascending doses of MORF-057 administered orally to healthy adult subjects
Time frame: Day -1 to Day 28
Subject incidence of adverse events and serious adverse events
Maximum Plasma Concentration (Cmax) of MORF-057 in a fed state
Time frame: Day -1 to Day 28
Cmax (Food Effect cohort)
Time to Reach Cmax (Tmax) of MORF-057 in a fed state
Time frame: Day -1 to Day 28
Tmax (Food Effect cohort)
3 secondary outcomes
Maximum Plasma Concentration (Cmax) during single and multiple ascending doses of MORF-057
Time frame: Day -1 to Day 28
Time to Reach Cmax (Tmax) during single and multiple ascending doses of MORF-057
Time frame: Day -1 to Day 28
Incidence of adverse events and safety signals observed during single dose of MORF-057 administered after a meal to healthy subjects.
Time frame: Day -1 to Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MORF-057 in people with Healthy Volunteers, run by Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company) at 1 site in United States.
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 4 inclusion and 5 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 1 Aug 2025. 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 United States. 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. 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?
Incidence of adverse events and safety signals observed during single and multiple ascending doses of MORF-057 administered orally to healthy adult subjects (time frame: Day -1 to Day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2025; AzTrials last refreshed its copy on 2 Nov 2026.