AcromegalyPhase 2NCT07641179
A Study to Evaluate MAR002 for Acromegaly
A Phase 2 study testing MAR002 in people with Acromegaly, run by Marea Therapeutics at 3 sites in United States.
Trial summary
Evaluate the safety and tolerability of subcutaneous (SC) administration of MAR002 in participants with acromegaly Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acromegaly
- What is being tested?
- MAR002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Jul 2026to Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Endocrinology Associates, Inc
Columbus, Ohio, 43201
Camila Caudy, 6143546215, camila@endocrinology-associates.com
Elena Christofides
- Recruiting
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Mary Thornton, 6024062768, mary.thornton@commonspirit.org
Kevin Yuen
- Recruiting
Consano Clinical Research
San Antonio, Texas, 78258
Marissa Flores, 2105454900, Marissa@consanosa.com
Daniel Katselnik
About this study
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)
Evaluate the safety and tolerability of subcutaneous (SC) administration of MAR002 in participants with acromegaly
Read the 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").
- Conditions
- Acromegaly
- Being tested
- MAR002, Placebo
- Keywords
- Marea, MAR002, MAR-202
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAR002Drug
Subcutaneous injection
PlaceboDrug
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| MAR002 Dose 1 | Experimental | Subcutaneous injection Receives: Drug: MAR002 |
| MAR002 Dose 2 | Experimental | Subcutaneous injection Receives: Drug: MAR002 |
| MAR002 Dose 3 | Experimental | Subcutaneous injection Receives: Drug: MAR002 |
| Matched Placebo | Placebo comparator | Subcutaneous Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline to Week 10
Secondary outcomes (4)
Change from baseline in acromegaly symptoms as measured by the Acromegaly Quality of Life (AcroQoL)
To explore the effects of MAR002 on acromegaly symptoms
Measured: Baseline to Week 10
Change from baseline in acromegaly symptoms as measured by Investigator assessment
To explore the effects of MAR002 on acromegaly symptoms
Measured: Baseline to Week 10
Change from baseline in ring size
To explore the effects of MAR002 on acromegaly symptoms
Measured: 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
Measured: Baseline to Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start23 Jul 2026
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marea Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641179
- Sponsor's protocol ID
- MAR-202
- Status last verified
- Sep 2026
- First submitted
- 26 May 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No