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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07641179
- Acronym / sponsor ID
- MAR-202
- Conditions
- Acromegaly
- Keywords
- Marea, MAR002, MAR-202
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Marea TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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").
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MAR002 Dose 1 | Experimental | Drug: MAR002Subcutaneous injection |
| MAR002 Dose 2 | Experimental | Drug: MAR002Subcutaneous injection |
| MAR002 Dose 3 | Experimental | Drug: MAR002Subcutaneous injection |
| Matched Placebo | Placebo comparator | Drug: PlaceboSubcutaneous Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAR002Subcutaneous injection | Drug | MAR002 Dose 1, MAR002 Dose 2, MAR002 Dose 3 |
| PlaceboSubcutaneous injection | Drug | Matched Placebo |
Primary outcome
Number of participants with TEAEs (treatment-emergent adverse events), SAEs (serious adverse events), and other laboratory endpoints
Time frame: 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
Time frame: Baseline to Week 10
To assess the effect of MAR002 on serum insulin-like growth factor 1 (IGF-1) levels in participants with acromegaly
4 secondary outcomes
Change from baseline in acromegaly symptoms as measured by the Acromegaly Quality of Life (AcroQoL)
Time frame: Baseline to Week 10
Change from baseline in acromegaly symptoms as measured by Investigator assessment
Time frame: Baseline to Week 10
Change from baseline in ring size
Time frame: Baseline to Week 10
Change from baseline in acromegaly symptoms as measured by the Acromegaly Symptom Diary (ASD)
Time frame: Baseline to Week 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Acromegaly
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Acromegaly
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia
Not yet recruitingPhase 3
PRESTO: A Phase III Randomised Controlled Trial of Dose-escalated Proton Beam Therapy Versus Standard of Care Radiotherapy for Functioning Pituitary Tumours
Acromegaly Due to Pituitary Adenoma, Cushing's Disease
RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
St. Joseph's Hospital and Medical Center
Phoenix, United States
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MAR002 in people with Acromegaly, run by Marea Therapeutics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with TEAEs (treatment-emergent adverse events), SAEs (serious adverse events), and other laboratory endpoints (time frame: Baseline to Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.