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Recruiting Phase 2

A Study to Evaluate MAR002 for Acromegaly

NCT07641179 · tracked via the Priya Life Science USA tracker
Phase
Phase 2
Started
2026-07-23
Last updated
2026-09-11

Condition(s) studied

Acromegaly

Investigational drug(s) / intervention(s)

MAR002 →Placebo

MAR002: Subcutaneous injection

Placebo: Subcutaneous injection

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Willing to provide written informed consent 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 × ULN 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: 1. History of hypersensitivity to monoclonal antibodies. 2. 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. 3. History of severe allergic or anaphylactic reactions. 4. 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. 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 hemoglobin A1c (HbA1c) ≥ 9.0%. 8. 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. 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 transient ischemic attack.

Primary outcome measure(s)

  • Number of participants with TEAEs (treatment-emergent adverse events), SAEs (serious adverse events), and other laboratory endpoints — Baseline to Week 16
    To assess the safety and tolerability of multiple subcutaneous (SC) dose administrations of MAR002 in participants with acromegaly
  • Percent change from baseline in serum insulin-like growth factor 1 (IGF-1) levels as an average of Week 8 and Week 10 — Baseline to Week 10
    To assess the effect of MAR002 on serum insulin-like growth factor 1 (IGF-1) levels in participants with acromegaly

Trial sites (3)

FacilityCityRegionStatus
St. Joseph's Hospital and Medical Center Phoenix Arizona Recruiting
Endocrinology Associates, Inc Columbus Ohio Recruiting
Consano Clinical Research San Antonio Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07641179 on ClinicalTrials.gov ↗ ← All trials in the USA