Acromegaly
Conditions
Keywords
Marea, MAR002, MAR-202
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").
Interventions
DRUGMAR002
Subcutaneous injection
DRUGPlacebo
Subcutaneous injection
Sponsors
Marea Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with TEAEs (treatment-emergent adverse events), SAEs (serious adverse events), and other laboratory endpoints | Baseline to Week 16 | To assess the safety and tolerability of multiple subcutaneous (SC) dose administrations of MAR002 in participants with acromegaly |
| Percent change from baseline in serum insulin-like growth factor 1 (IGF-1) levels as an average of Week 8 and Week 10 | Baseline to Week 10 | To assess the effect of MAR002 on serum insulin-like growth factor 1 (IGF-1) levels in participants with acromegaly |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in acromegaly symptoms as measured by the Acromegaly Quality of Life (AcroQoL) | Baseline to Week 10 | To explore the effects of MAR002 on acromegaly symptoms |
| Change from baseline in acromegaly symptoms as measured by Investigator assessment | Baseline to Week 10 | To explore the effects of MAR002 on acromegaly symptoms |
| Change from baseline in ring size | Baseline to Week 10 | To explore the effects of MAR002 on acromegaly symptoms |
| Change from baseline in acromegaly symptoms as measured by the Acromegaly Symptom Diary (ASD) | Baseline to Week 10 | To explore the effects of MAR002 on acromegaly symptoms |
Countries
United States
Outcome results
None listed