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RecruitingNCT07195175Updated Jan 12, 2026

Study of MAR002 in Healthy Men

A Phase 1 interventional study of MAR002 and Placebo in Acromegaly, sponsored by Marea Therapeutics. Recruiting at 1 site in United States. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-12.

Sponsored by Marea Therapeutics · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Aug 2025; still recruiting 1 year 3 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Acromegaly

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03

In context

Acromegaly

202 studies on the registry are indexed under Acromegaly; 19 are open to participants now.

This study's planned enrollment of 45 is close to the median of 43 across 115 interventional studies indexed under Acromegaly.

Browse Acromegaly studies →

Lead sponsor

Marea Therapeutics is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. History of to monoclonal antibodies or study drug
  2. Participation in any other drug study
  3. History of cancer
  4. Recent acute illness
  5. Positive test for , /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
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Dose A MAR002

    Subcutaneous injection

    Drug: MAR002 · Drug: Placebo

  • Experimental
    Dose B MAR002

    Cohort 2 receiving single Dose B

    Drug: MAR002 · Drug: Placebo

  • Experimental
    Dose C MAR002

    Cohort 3 receiving single Dose C

    Drug: MAR002 · Drug: Placebo

  • Experimental
    Dose D MAR002

    Cohort 4 receiving single Dose D

    Drug: MAR002 · Drug: Placebo

  • Experimental
    Dose E MAR002

    Cohort 5 receiving single Dose E

    Drug: MAR002 · Drug: Placebo

  • Experimental
    Dose F MAR002

    Cohort 6 receiving multiple Dose F

    Drug: MAR002 · Drug: Placebo

Interventions

  • DrugMAR002

    subcutaneous injection

  • DrugPlacebo

    Subcutaneous injection

06

What researchers measure

Primary outcomes

  1. Number of participants with TEAEs (treatment-emergent adverse events)

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

    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.

Secondary outcomes

  1. PK Parameters -- Cmax

    To evaluate the PK parameters through plasma concentration (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.

  2. PK Parameters - Tmax

    To evaluate the PK parameters through plasma concentration (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.

  3. PK Parameters - AUC

    To evaluate the PK parameters through plasma concentration (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.

  4. PK Parameters - Half Life

    To evaluate the PK parameters through plasma concentration (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.

  5. PK Parameters - Clearance

    To evaluate the PK parameters through plasma concentration (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.

  6. PK Parameters - MRT

    To evaluate the PK parameters through plasma concentration (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.

07

Study locations

1 of 1 sites recruiting
  • Marea Site
    Tempe, Arizona 85283, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07195175
Lead sponsor
Marea Therapeutics
Responsible party
Sponsor
First posted
Sep 26, 2025
Start date
Aug 11, 2025
Primary completion
Jul 2026 (estimated)
Completion
Jul 2026 (estimated)
Last update
Jan 12, 2026

Study contacts

Andrew Lane
Contact
mar-201-info@mareatx.com
415-766-3610

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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