A Study to Evaluate MAR002 for Acromegaly
ConditionAcromegaly
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMarea Therapeutics
About this trial
Evaluate the safety and tolerability of subcutaneous (SC) administration of MAR002 in participants with acromegaly
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
MAR002
DrugSubcutaneous injection
Placebo
DrugSubcutaneous injection
Treatment groups
72 Participants
are divided into 4 treatment groupsGroup A: MAR002 Dose 1Experimental treatment 1 intervention
Group B: MAR002 Dose 2Experimental treatment 1 intervention
Group C: MAR002 Dose 3Experimental treatment 1 intervention
Group D: Matched PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 162
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 10Secondary outcomes
1
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 102
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 103
Change from baseline in ring size
To explore the effects of MAR002 on acromegaly symptoms
Time frame
Baseline to Week 104
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 10Sponsors and contacts
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Source ClinicalTrials.gov