A Study to Evaluate MAR002 for Acromegaly

NCT07641179 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MAR-202
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Acromegaly

Keywords

Marea; MAR002; MAR-202

Outcome Measures

Primary Outcomes (2)

• 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

  Baseline to Week 16

• 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

  Baseline to Week 10

Secondary Outcomes (4)

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

  Baseline to Week 10

• Change from baseline in acromegaly symptoms as measured by Investigator assessment

  Baseline to Week 10

• Change from baseline in ring size

  Baseline to Week 10

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

  Baseline to Week 10

Study Arms (4)

MAR002 Dose 1

EXPERIMENTAL

Subcutaneous injection

Drug: MAR002

MAR002 Dose 2

EXPERIMENTAL

Subcutaneous injection

Drug: MAR002

MAR002 Dose 3

EXPERIMENTAL

Subcutaneous injection

Drug: MAR002

Matched Placebo

PLACEBO COMPARATOR

Subcutaneous Placebo

Drug: Placebo

Interventions

MAR002 DRUG

Subcutaneous injection

MAR002 Dose 1; MAR002 Dose 2; MAR002 Dose 3

Placebo DRUG

Subcutaneous injection

Matched Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to provide written informed consent and comply with study procedures as specified in this protocol and comply with study treatment.
• 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.
• 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.
• Average serum IGF-1 level of ≥ 1.3 × ULN defined as the mean of 2 measurements obtained ≥ 1 week apart during Screening.
• Participants with hypothyroidism and adrenal insufficiency should have these hormone axes adequately replaced as judged by the Investigator.
• Weight ≥ 50 kg at screening.

You may not qualify if:

• History of hypersensitivity to monoclonal antibodies.
• Participation in any other investigational drug study and received the last dose of investigational drug within 60 days or 5 half-lives (whichever is longer) of SV1.
• History of severe allergic or anaphylactic reactions.
• History of malignancy 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.
• Pituitary surgery in the past 6 months prior to screening or any prior use of pituitary radiation therapy.
• 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.
• Poorly controlled diabetes mellitus, defined as having a hemoglobin A1c (HbA1c) ≥ 9.0%.
• Severe renal insufficiency (estimated glomerular filtration rate \[eGFR by Chronic Kidney Disease Epidemiology Collaboration\] \< 30 mL/min/1.73 m2) or significant liver disease (including cirrhosis) prior to randomization.
• 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 transient ischemic attack.

Sponsors & Collaborators

• Marea Therapeutics: lead

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 11, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share