72 Participants NeededMy employer runs this trial

MAR002 for Acromegaly

Recruiting at 2 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Marea Therapeutics
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called MAR002 for individuals with acromegaly, a condition characterized by excessive growth hormone production. The main goal is to assess the safety and tolerability of different doses of MAR002 when administered as an injection under the skin. Participants with acromegaly who have had a pituitary tumor confirmed by a doctor and have experienced high levels of growth hormone in the past are suitable candidates for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to significant advancements in acromegaly treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that MAR002 is likely safe based on earlier studies. Participants in these studies did not experience serious side effects, even at higher doses, indicating that the treatment was well-tolerated. No safety concerns were directly linked to the drug, suggesting that MAR002 is generally safe for use.12345

Why are researchers excited about this trial's treatments?

Most treatments for acromegaly, like somatostatin analogs, work by reducing growth hormone production. But MAR002 is different because it targets the growth hormone receptor directly, potentially providing a more precise approach. Administered as a subcutaneous injection, this treatment could offer a new option for patients who struggle with current therapies. Researchers are particularly excited about MAR002's potential to better manage the condition with fewer side effects, making life easier for those with acromegaly.

What evidence suggests that MAR002 might be an effective treatment for acromegaly?

Studies have shown that MAR002 can effectively lower IGF-1 levels, which are often elevated in people with acromegaly. In previous research, MAR002 reduced IGF-1 levels by up to 52% at the highest dose. This effect lasted for up to 43 days, demonstrating its prolonged efficacy. As a long-acting antibody, the treatment remains in the body longer, providing sustained action. Overall, these findings suggest that MAR002 could be a strong option for managing acromegaly symptoms.34678

Are You a Good Fit for This Trial?

This trial is for adults aged 18–75 with active acromegaly, confirmed by a pituitary tumor and high IGF-1 levels. Participants must be able to follow study procedures, weigh at least 50 kg, and have stable hormone replacement if they have thyroid or adrenal issues.

Inclusion Criteria

4. Average serum IGF-1 level of ≥ 1.3 × ULN defined as the mean of 2 measurements obtained ≥ 1 week apart during Screening.
I am 18 to 75 years old and have active acromegaly with a confirmed pituitary tumor.
1. Willing to provide written informed consent and comply with study procedures as specified in this protocol and comply with study treatment.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous injections of MAR002 or placebo every 2 weeks for a 10-week period

10 weeks
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • MAR002

Trial Overview

The study tests the safety of MAR002 (given as an injection under the skin) compared to a placebo in people with acromegaly. Some participants may need to stop their current acromegaly medications before joining.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: MAR002 Dose 3Experimental Treatment1 Intervention
Group II: MAR002 Dose 2Experimental Treatment1 Intervention
Group III: MAR002 Dose 1Experimental Treatment1 Intervention
Group IV: Matched PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Marea Therapeutics

Lead Sponsor

Trials
1
Recruited
60+

Citations

Marea reports positive Phase I results for MAR002 trial in ...

Treatment resulted in dose-dependent IGF-1 reductions; peak suppression was 52% at the highest dose, over 45% lasted 43 days.

Marea Therapeutics to Present Data from Phase 1 Study of ...

The in vivo PK and PD properties of MAR002 are predictable and typical of a half-life extended human antibody, showing a long duration of action ...

NCT07195175 | Study of MAR002 in Healthy Men

Funder outcome measures. The types of primary purpose are: treatment, prevention, diagnostic, supportive care, screening, health services research, basic ...

Marea Therapeutics Unveils Positive Topline Phase 1 Data ...

Treatment with MAR002 resulted in robust and durable dose-dependent reductions … peak suppression of 52% 45% suppression out to 43 days.

Acromegaly Market Size Analysis | Research Report 2036

Marea announced positive Phase I topline results for MAR002 in acromegaly, highlighting potential for best-in-class efficacy and a favorable dosing profile.

Marea Therapeutics Presents Phase 1 Data Supporting ...

MAR002 demonstrated a favorable safety and tolerability profile, with no serious adverse events or dose-limiting toxicities.

OR12-06 Development of a Novel Growth Hormone Receptor ...

This work enables continued MAR002 development to assess its safety, efficacy, and potential to improve the care for patients with acromegaly.

Marea Therapeutics Unveils Positive Topline Phase 1 Data ...

MAR002 demonstrated a favorable safety and tolerability profile, with no drug-related safety signals observed.