A Study to Evaluate MAR002 for Acromegaly
9 september 2026 uppdaterad av: Marea Therapeutics
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)
Evaluate the safety and tolerability of subcutaneous (SC) administration of MAR002 in participants with acromegaly
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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").
Studietyp
Interventionell
Inskrivning (Beräknad)
72
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Arizona
-
Phoenix, Arizona, Förenta staterna, 85013
- Rekrytering
- St. Joseph's Hospital and Medical Center
-
Kontakt:
- Mary Thornton
- Telefonnummer: 6024062768
- E-post: mary.thornton@commonspirit.org
-
Huvudutredare:
- Kevin Yuen
-
-
Ohio
-
Columbus, Ohio, Förenta staterna, 43201
- Rekrytering
- Endocrinology Associates, Inc
-
Huvudutredare:
- Elena Christofides
-
Kontakt:
- Camila Caudy
- Telefonnummer: 6143546215
- E-post: camila@endocrinology-associates.com
-
-
Texas
-
San Antonio, Texas, Förenta staterna, 78258
- Rekrytering
- Consano Clinical Research
-
Huvudutredare:
- Daniel Katselnik
-
Kontakt:
- Marissa Flores
- Telefonnummer: 2105454900
- E-post: Marissa@consanosa.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: MAR002 Dose 1
Subcutaneous injection
|
Subcutaneous injection
|
|
Experimentell: MAR002 Dose 2
Subcutaneous injection
|
Subcutaneous injection
|
|
Experimentell: MAR002 Dose 3
Subcutaneous injection
|
Subcutaneous injection
|
|
Placebo-jämförare: Matched Placebo
Subcutaneous Placebo
|
Subkutan injektion
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of participants with TEAEs (treatment-emergent adverse events), SAEs (serious adverse events), and other laboratory endpoints
Tidsram: Baseline to Week 16
|
To assess the safety and tolerability of multiple subcutaneous (SC) dose administrations of MAR002 in participants with acromegaly
|
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
Tidsram: Baseline to Week 10
|
To assess the effect of MAR002 on serum insulin-like growth factor 1 (IGF-1) levels in participants with acromegaly
|
Baseline to Week 10
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from baseline in ring size
Tidsram: Baseline to Week 10
|
To explore the effects of MAR002 on acromegaly symptoms
|
Baseline to Week 10
|
|
Change from baseline in acromegaly symptoms as measured by the Acromegaly Quality of Life (AcroQoL)
Tidsram: Baseline to Week 10
|
To explore the effects of MAR002 on acromegaly symptoms
|
Baseline to Week 10
|
|
Change from baseline in acromegaly symptoms as measured by Investigator assessment
Tidsram: Baseline to Week 10
|
To explore the effects of MAR002 on acromegaly symptoms
|
Baseline to Week 10
|
|
Change from baseline in acromegaly symptoms as measured by the Acromegaly Symptom Diary (ASD)
Tidsram: Baseline to Week 10
|
To explore the effects of MAR002 on acromegaly symptoms
|
Baseline to Week 10
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
23 juli 2026
Primärt slutförande (Beräknad)
1 augusti 2027
Avslutad studie (Beräknad)
1 december 2027
Studieregistreringsdatum
Först inskickad
26 maj 2026
Först inskickad som uppfyllde QC-kriterierna
8 juni 2026
Första postat (Faktisk)
11 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MAR-202
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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