Recruiting
Phase 1

MAR002

Sponsor:

Marea Therapeutics

Code:

NCT07195175

Conditions

Acromegaly

Eligibility Criteria

Sex: Male

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

MAR002

Placebo

Study Details

Brief summary:

Evaluate the safety and tolerability of subcutaneous (SC) administration of MAR002 in healthy men

Conditions

Acromegaly

Study ID

NCT07195175

Start date

Aug 11, 2025

Status verified date

Jan, 2026

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Willingness to provide written informed consent
2. Age 18 to 40
3. Weight 55 to 95 kg
4. Body mass index (BMI) 18 to 30 kg/m2
5. Healthy men

Exclusion Criteria:

1. History of hypersensitivity to monoclonal antibodies or study drug
2. Participation in any other investigational drug study
3. History of cancer
4. Recent acute illness
5. Positive test for HIV, hepatitis B/C
6. History of substance abuse or nicotine use
7. Recent blood donation
8. History of pituitary disorder
9. Any condition that prevents the participant from complying with study procedures

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose A MAR002

Subcutaneous injection

experimental: Dose B MAR002

Cohort 2 receiving single Dose B

experimental: Dose C MAR002

Cohort 3 receiving single Dose C

experimental: Dose D MAR002

Cohort 4 receiving single Dose D

experimental: Dose E MAR002

Cohort 5 receiving single Dose E

experimental: Dose F MAR002

Cohort 6 receiving multiple Dose F

Interventions

MAR002

subcutaneous injection

Placebo

Subcutaneous injection

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. ]

Central Contacts and Locations

Central contacts

Andrew Lane

415-766-3610mar-201-info@mareatx.com

Locations

Marea Site

Recruiting

Tempe, Arizona, United States, 85283

More Information

Sponsor

Marea Therapeutics

Last update posted

Jan 12, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Marea Therapeutics on 2026-01-12.