Evaluate the safety and tolerability of subcutaneous (SC) administration of MAR002 in participants with acromegaly
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").
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
72
Number of participants with TEAEs (treatment-emergent adverse events), SAEs (serious adverse events), and other laboratory endpoints
To assess the safety and tolerability of multiple subcutaneous (SC) dose administrations of MAR002 in participants with acromegaly
Time frame: 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
To assess the effect of MAR002 on serum insulin-like growth factor 1 (IGF-1) levels in participants with acromegaly
Time frame: Baseline to Week 10
Change from baseline in acromegaly symptoms as measured by the Acromegaly Quality of Life (AcroQoL)
To explore the effects of MAR002 on acromegaly symptoms
Time frame: Baseline to Week 10
Change from baseline in acromegaly symptoms as measured by Investigator assessment
To explore the effects of MAR002 on acromegaly symptoms
Time frame: Baseline to Week 10
Change from baseline in ring size
To explore the effects of MAR002 on acromegaly symptoms
Time frame: Baseline to Week 10
Change from baseline in acromegaly symptoms as measured by the Acromegaly Symptom Diary (ASD)
To explore the effects of MAR002 on acromegaly symptoms
Time frame: Baseline to Week 10
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