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(352) 733-0111

RM-493-022

  • Status
    Accepting Candidates
  • Age
    2 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

This is a long-term extension trial to study the safety and tolerability of continued setmelanotide treatment in patients who have completed a previous clinical trial on treatment with setmelanotide for obesity associated with genetic defects upstream of the MC4 receptor in the leptin-melanocortin pathway.

Description

The primary objectives of this extension trial are to explore the long-term safety and tolerability of setmelanotide for up to 5 years or until drug is otherwise available through authorized use. Patients can enter this protocol immediately upon completion of their index protocol such that dosing of setmelanotide continues without gaps in therapy.

Details

Full study title Long Term Extension Trial of Setmelanotide (RM-493) for patients who have completed a trial of Setmelanotide for the treatment of obesity associated with genetic defects upstream of the MC4 receptor in the leptin-melanocortin pathway
Protocol number OCR29982
ClinicalTrials.gov ID NCT03651765
Phase Phase 2/Phase 3

Eligibility

Key Inclusion Criteria:

  1. Patients aged 2 or older (or aged >2 years as per local regulations) who have completed participation in a previous setmelanotide trial and demonstrated adequate safety and meaningful clinical benefit (efficacy)

  2. Patient and/or parent or guardian is able to communicate with the investigator, understand and sign the written informed consent/assent, and comply with the trial requirements

  3. Agree to use a highly effective form of contraception throughout the trial

Key Exclusion Criteria:

  1. Pregnant and/or breastfeeding women

  2. Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion)

  3. Current, clinically significant disease

  4. Documented diagnosis of schizophrenia, bipolar disorder, personality disorder, major depressive disorder, or other psychiatric disorder(s)

  5. Suicidal ideation, attempt or behavior

  6. History of significant liver disease

  7. Moderate to severe renal dysfunction as defined by a glomerular filtration rate (GFR)

Lead researcher

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

    Jennifer Miller
  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.