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)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 3
研究概览
简要总结
Evaluate the safety and tolerability of subcutaneous (SC) administration of MAR002 in participants with acromegaly
详细描述
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").
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 SV
- •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.
研究组 & 干预措施
MAR002 Dose 1
Subcutaneous injection
干预措施: MAR002 (Drug)
MAR002 Dose 2
Subcutaneous injection
干预措施: MAR002 (Drug)
MAR002 Dose 3
Subcutaneous injection
干预措施: MAR002 (Drug)
Matched Placebo
Subcutaneous Placebo
干预措施: Placebo (Drug)