A Study to Evaluate MAR002 for Acromegaly
brief summary
Evaluate the safety and tolerability of subcutaneous (SC) administration of MAR002 in participants with acromegaly
detailed description
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").
official title
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)