AcromegalyPhase 1NCT07195175
Study of MAR002 in Healthy Men
A Phase 1 study testing MAR002 in people with Acromegaly, run by Marea Therapeutics at 1 site in United States.
Trial summary
Evaluate the safety and tolerability of subcutaneous (SC) administration of MAR002 in healthy men Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Acromegaly
- What is being tested?
- MAR002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2025to Jul 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willingness to provide written informed consent
- Age 18 to 40
- Weight 55 to 95 kg
- Body mass index (BMI) 18 to 30 kg/m2
- Healthy men
Who cannot join
- History of hypersensitivity to monoclonal antibodies or study drug
- Participation in any other investigational drug study
- History of cancer
- Recent acute illness
- Positive test for HIV, hepatitis B/C
- History of substance abuse or nicotine use
Show all 9Show fewer
- Recent blood donation
- History of pituitary disorder
- Any condition that prevents the participant from complying with study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Marea Site
Tempe, Arizona, 85283
About this study
Official title: First in Human, Randomized, Blinded, Placebo-Controlled Single Ascending Dose and Multiple Dose Study of MAR002 in Healthy Men
Evaluate the safety and tolerability of subcutaneous (SC) administration of MAR002 in healthy men
- Conditions
- Acromegaly
- Being tested
- MAR002, Placebo
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAR002Drug
subcutaneous injection
PlaceboDrug
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Dose A MAR002 | Experimental | Subcutaneous injection Receives: Drug: MAR002; Drug: Placebo |
| Dose B MAR002 | Experimental | Cohort 2 receiving single Dose B Receives: Drug: MAR002; Drug: Placebo |
| Dose C MAR002 | Experimental | Cohort 3 receiving single Dose C Receives: Drug: MAR002; Drug: Placebo |
| Dose D MAR002 | Experimental | Cohort 4 receiving single Dose D Receives: Drug: MAR002; Drug: Placebo |
| Dose E MAR002 | Experimental | Cohort 5 receiving single Dose E Receives: Drug: MAR002; Drug: Placebo |
| Dose F MAR002 | Experimental | Cohort 6 receiving multiple Dose F Receives: Drug: MAR002; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with TEAEs (treatment-emergent adverse events)
To evaluate the safety and tolerability of subcutaneous (SC) administration of MAR002 in healthy men
Measured: From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.
Secondary outcomes (6)
PK Parameters -- Cmax
To evaluate the PK parameters through plasma concentration (Cmax)
Measured: From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.
PK Parameters - Tmax
To evaluate the PK parameters through plasma concentration (Tmax)
Measured: From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.
PK Parameters - AUC
To evaluate the PK parameters through plasma concentration (AUC)
Measured: From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.
PK Parameters - Half Life
To evaluate the PK parameters through plasma concentration (Half Life)
Measured: From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.
PK Parameters - Clearance
To evaluate the PK parameters through plasma concentration (Clearance)
Measured: From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.
PK Parameters - MRT
To evaluate the PK parameters through plasma concentration (MRT)
Measured: From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start11 Aug 2025
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Randomized, Double-Blind (sponsor unblinded), placebo-controlled single ascending dose and multiple dose
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marea Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195175
- Sponsor's protocol ID
- MAR-201
- Status last verified
- Jan 2026
- First submitted
- 27 Aug 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First in Human, Randomized, Blinded, Placebo-Controlled Single Ascending Dose and Multiple Dose Study of MAR002 in Healthy Men
- ClinicalTrials.gov ID
- NCT07195175
- Acronym / sponsor ID
- MAR-201
- Conditions
- Acromegaly
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Marea TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 26 Sep 2025 (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.
Evaluate the safety and tolerability of subcutaneous (SC) administration of MAR002 in healthy men
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
- Model description
- Randomized, Double-Blind (sponsor unblinded), placebo-controlled single ascending dose and multiple dose
| Arm | Type | Receives |
|---|---|---|
| Dose A MAR002 | Experimental | Drug: MAR002, Drug: PlaceboSubcutaneous injection |
| Dose B MAR002 | Experimental | Drug: MAR002, Drug: PlaceboCohort 2 receiving single Dose B |
| Dose C MAR002 | Experimental | Drug: MAR002, Drug: PlaceboCohort 3 receiving single Dose C |
| Dose D MAR002 | Experimental | Drug: MAR002, Drug: PlaceboCohort 4 receiving single Dose D |
| Dose E MAR002 | Experimental | Drug: MAR002, Drug: PlaceboCohort 5 receiving single Dose E |
| Dose F MAR002 | Experimental | Drug: MAR002, Drug: PlaceboCohort 6 receiving multiple Dose F |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Willingness to provide written informed consent
- Age 18 to 40
- Weight 55 to 95 kg
- Body mass index (BMI) 18 to 30 kg/m2
- Healthy men
Key exclusion criteria (9 listed)
- History of hypersensitivity to monoclonal antibodies or study drug
- Participation in any other investigational drug study
- History of cancer
- Recent acute illness
- Positive test for HIV, hepatitis B/C
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 |
|---|---|---|
| MAR002subcutaneous injection | Drug | Dose A MAR002, Dose B MAR002, Dose C MAR002, Dose D MAR002, Dose E MAR002, Dose F MAR002 |
| PlaceboSubcutaneous injection | Drug | Dose A MAR002, Dose B MAR002, Dose C MAR002, Dose D MAR002, Dose E MAR002, Dose F MAR002 |
Primary outcome
Number of participants with TEAEs (treatment-emergent adverse events)
Time frame: From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.
To evaluate the safety and tolerability of subcutaneous (SC) administration of MAR002 in healthy men
6 secondary outcomes
PK Parameters -- Cmax
Time frame: From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.
PK Parameters - Tmax
Time frame: From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.
PK Parameters - AUC
Time frame: From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.
PK Parameters - Half Life
Time frame: From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.
PK Parameters - Clearance
Time frame: From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.
PK Parameters - MRT
Time frame: From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 MAR002 in people with Acromegaly, run by Marea Therapeutics 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 12 Jan 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Lane (415-766-3610, mar-201-info@mareatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with TEAEs (treatment-emergent adverse events) (time frame: From first dose of study drug through final End of Study/Early Termination Visit. End of Study is Day 64 for Cohorts 1 and 2; End of Study is day 169 for Cohorts 3, 4, 5, and 6.). 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 12 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.