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RecruitingNCT07641179Updated Sep 11, 2026

A Study to Evaluate MAR002 for Acromegaly

A Phase 2 interventional study of MAR002 and Placebo in Acromegaly, sponsored by Marea Therapeutics. Recruiting at 3 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Marea Therapeutics · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Evaluate the safety and tolerability of subcutaneous (SC) administration of MAR002 in participants with acromegaly

Read the detailed description

MAR-202 is a randomized, multicenter, double-blind, placebo-controlled dose-range finding study.

After screening, participants who meet all eligibility criteria will be randomized to 1 of 3 active MAR002 regimens or matching placebo in a 3:1 ratio for a 10-week Treatment Period. During the Treatment Period, study drug (MAR002 or matching placebo) will be administered at study visits every 2 weeks (Q2W; Days 1, 15, 29, 43, and 57) followed then by a Follow-up Period before the End of Study (EOS) Visit on Week 16.

This study will aim to enroll a total of approximately 72 participants with acromegaly across 3 groups (Group 1: "untreated"; Group 2: "controlled on medical therapy"; Group 3: "uncontrolled on medical therapy").

02

Conditions studied

  • Acromegaly

Browse trials for

Keywords

  • Marea
  • MAR002
  • MAR-202
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 72 is above 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 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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. Willing to provide written and comply with study procedures as specified in this protocol and comply with study treatment.
  2. Age 18 to 75 years (inclusive) at screening with active acromegaly confirmed by an endocrinologist specialized in the care of pituitary patients. At a minimum, there must be documentation of a pituitary tumor (e.g., imaging evidence of a pituitary tumor by magnetic resonance imaging [MRI]/computerized tomography [CT] or histopathologic evidence of pituitary adenoma following pituitary surgery) and an elevated IGF-1 in the past.
  3. Participants receiving acromegaly medical therapy at screening (i.e., Group 2 and Group 3) may be enrolled if the regimen is considered stable by the Investigator and must agree to wash out acromegaly treatment, if applicable per protocol.
  4. Average serum IGF-1 level of ≥ 1.3 × defined as the mean of 2 measurements obtained ≥ 1 week apart during Screening.
  5. Participants with hypothyroidism and adrenal insufficiency should have these hormone axes adequately replaced as judged by the Investigator.
  6. Weight ≥ 50 kg at screening.

Exclusion criteria

Exclusion Criteria:

  1. History of to monoclonal antibodies.
  2. Participation in any other drug study and received the last dose of investigational drug within 60 days or 5 half-lives (whichever is longer) of SV1.
  3. History of severe allergic or anaphylactic reactions.
  4. History of within 5 years prior to screening other than successfully treated basal or squamous cell carcinoma or localized cervical carcinoma. Any carcinoma in situ is allowed if appropriately treated within 2 years prior to screening. Subjects with a history of malignancy ≥ 5 years prior to screening should be considered cured of their oncological disease.
  5. Pituitary surgery in the past 6 months prior to screening or any prior use of pituitary radiation therapy.
  6. Pituitary adenoma with concern for mass effect on the optic chiasm or other critical structures within the study period as per judgment of the Investigator.
  7. Poorly controlled diabetes mellitus, defined as having a (HbA1c) ≥ 9.0%.
  8. Severe renal insufficiency (estimated [eGFR by Chronic Kidney Disease Epidemiology Collaboration] \< 30 mL/min/1.73 m2) or significant liver disease (including cirrhosis) prior to randomization.
  9. History or evidence of any of the following within the previous 12 months: myocardial infarction, cardiac surgery revascularization (coronary artery bypass grafting or percutaneous transluminal coronary angioplasty), hospitalization for heart failure, or stroke or .
Terms in these criteria, in plain language(8)

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.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

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.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
72 participants (estimated)

Study arms

  • Experimental
    MAR002 Dose 1

    Subcutaneous injection

    Drug: MAR002

  • Experimental
    MAR002 Dose 2

    Subcutaneous injection

    Drug: MAR002

  • Experimental
    MAR002 Dose 3

    Subcutaneous injection

    Drug: MAR002

  • Placebo comparator
    Matched Placebo

    Subcutaneous Placebo

    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), SAEs (serious adverse events), and other laboratory endpoints

    To assess the safety and tolerability of multiple subcutaneous (SC) dose administrations of MAR002 in participants with acromegaly

    Time frame: Baseline to Week 16

  2. Percent change from baseline in serum insulin-like growth factor 1 (IGF-1) levels as an average of Week 8 and Week 10

    To assess the effect of MAR002 on serum insulin-like growth factor 1 (IGF-1) levels in participants with acromegaly

    Time frame: Baseline to Week 10

Secondary outcomes

  1. Change from baseline in acromegaly symptoms as measured by the Acromegaly Quality of Life (AcroQoL)

    To explore the effects of MAR002 on acromegaly symptoms

    Time frame: Baseline to Week 10

  2. Change from baseline in acromegaly symptoms as measured by Investigator assessment

    To explore the effects of MAR002 on acromegaly symptoms

    Time frame: Baseline to Week 10

  3. Change from baseline in ring size

    To explore the effects of MAR002 on acromegaly symptoms

    Time frame: Baseline to Week 10

  4. Change from baseline in acromegaly symptoms as measured by the Acromegaly Symptom Diary (ASD)

    To explore the effects of MAR002 on acromegaly symptoms

    Time frame: Baseline to Week 10

07

Study locations

3 of 3 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

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 Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07641179
Lead sponsor
Marea Therapeutics
Responsible party
Sponsor
First posted
Jun 11, 2026
Start date
Jul 23, 2026
Primary completion
Aug 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Sep 11, 2026

Oversight

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

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No contact was published for this record. The registry link below has the sponsor’s details.

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