A Study to Evaluate MAR002 for Acromegaly

Официальное название

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo- Controlled, Multiple-Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MAR002 in Participants With Acromegaly (TROUGH-2)

Обзор

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

Подробное описание

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").

Вмешательства

• Препарат MAR002
  Subcutaneous injection
• Препарат Placebo
  Subcutaneous injection

Первичные конечные точки

• Number of participants with TEAEs (treatment-emergent adverse events), SAEs (serious adverse events), and other laboratory endpoints [Срок оценки: 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 [Срок оценки: Baseline to Week 10]

Вторичные конечные точки (4)

• Change from baseline in acromegaly symptoms as measured by the Acromegaly Quality of Life (AcroQoL) [Срок оценки: Baseline to Week 10]
• Change from baseline in acromegaly symptoms as measured by Investigator assessment [Срок оценки: Baseline to Week 10]
• Change from baseline in ring size [Срок оценки: Baseline to Week 10]
• Change from baseline in acromegaly symptoms as measured by the Acromegaly Symptom Diary (ASD) [Срок оценки: Baseline to Week 10]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07641179 · MAR-202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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