Test MAR002 for acromegaly in adults on or off medical therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, randomized, multicenter, double-blind, placebo-controlled study to find a dose range for MAR002 in adults with acromegaly. After screening, participants are assigned in a 3:1 ratio to one of three MAR002 regimens or placebo and receive injections every two weeks during a 10-week treatment period, followed by a follow-up and an end-of-study visit at week 16. Eligible participants include adults 18 to 75 with confirmed acromegaly and elevated IGF-1, with stratification into three groups based on prior medical therapy response. The study aims to enroll about 72 participants across three sites in the United States. Primary outcomes focus on safety and tolerability of SC MAR002 across dose ranges.

Why it matters

Who can join: the full rules

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.

Where it's running

• St. Joseph's Hospital and Medical Center
  Phoenix, Arizona, United States Recruiting
• Endocrinology Associates, Inc
  Columbus, Ohio, United States Recruiting
• Consano Clinical Research
  San Antonio, Texas, United States Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• NTQ6179 tablets first-in-human test in healthy adults

  This phase 1 study tests a single oral dose of NTQ6179 vs placebo in healthy adults to see if it is safe and how the body processes the drug.

  Recruiting Phase 1 Nanjing Chia-tai Tianqing Pharmaceutical · Beijing · NCT07909837

• Octreotide SC Depot in Acromegaly: Real-World Safety and Effectiveness

  This study follows people with acromegaly who are using octreotide subcutaneous depot to see how it works and how safe it is over up to two years in everyday clinical practice.

  Recruiting at 4 sites Camurus AB · Aachen and 6 other locations · NCT07583563

• MAR002 in healthy men

  This trial tests whether a subcutaneous injection of MAR002 is safe and tolerable in healthy men aged 18 to 40.

  Recruiting Phase 1 Marea Therapeutics · Tempe, Arizona · NCT07195175

• Pasireotide LAR and bone health in adults with acromegaly

  This study will test whether switching adults with uncontrolled acromegaly to pasireotide LAR changes bone turnover and the risk of vertebral fractures.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Rome, RM · NCT07179926

• Assessing Debio 4126 for treating acromegaly in patients on somatostatin analogs

  This study is testing if a new treatment called Debio 4126 can help people with acromegaly who are already on somatostatin analogs keep their IGF-1 levels in check better than a placebo.

  Recruiting at 72 sites Phase 3 Debiopharm International SA · Los Angeles, California and 73 other locations · NCT06930625

• Evaluating the effects of acromegaly on hand and foot dimensions and movement

  This study looks at how acromegaly affects the size and movement of hands and feet in patients to better understand the physical changes caused by the condition.

  Recruiting Istituto Auxologico Italiano · Milan · NCT05964712

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.