NL-OMON54784招募中3 期
ong 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 - Trial for who have completed a trial of RM-493 for treatment of obesity
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 64（—）
入选标准
- •1. Patients aged 2 or older (or aged >2 years as per local regulations; only
- •patients aged 12 years or older may be enrolled in the trial in Greece; only
- •patients 6 years or older may be enrolled in the trial in Germany) who have
- •completed participation in a previous setmelanotide clinical trial.
- •2. If patient received setmelanotide on an open-label basis in a previous
- •setmelanotide clinical trial, patient demonstrated adequate safety and
- •meaningful clinical benefit (efficacy) in the previous setmelanotide trial.
- •Meaningful clinical benefit is defined as follows:
- •Patients 18 years of age or younger that have completed participation on
- •active drug and demonstrated adequate safety and at least 3% BMI reduction or
- •reduction in BMI Z-score of 0.2 compared to baseline.
- •Patients over 18 years of age should show reduction of 3% BMI compared to
- •baseline. If the patient received trial drug in a double-blind basis in the
- •previous placebo-controlled clinical trial, patient tolerated trial drug in the
- •previous clinical trial.
- •3. Patient and/or parent or guardian is able to communicate well with the
- •Principal Investigator, to understand and comply with the requirements of the
- •trial, and to understand and sign the written informed consent/assent. The
- •patient must assent/consent to participate in the trial.
- •4. Patient must meet one of the following requirements regarding contraception:
- •If a female of childbearing potential, defined as fertile, following menarche
- •and until becoming post-menopausal unless permanently sterile (hysterectomy,
- •bilateral salpingectomy, or bilateral oophorectomy), must use a highly
- •effective form of contraception as outlined in Section 6.2.1.
- •If a female of non-childbearing potential, defined as permanently sterile
- •(status post hysterectomy, bilateral oophorectomy, or bilateral salpingectomy)
- •or post-menopausal for at least 12 months (and confirmed with a screening
- •follicle-stimulating hormone (FSH) level in the post-menopausal laboratory
- •range), contraception is not required during the trial.
- •* Younger female patients who have not reached menarche upon trial entry will
- •be assessed for Tanner staging and at first menarche will be required to comply
- •with contraception requirements and pregnancy testing as outlined in the
- •If a male with female partner(s) of childbearing potential, must agree to a
- •double barrier method if they become sexually active during the study.
- •Furthermore, male patients must not donate sperm during and for 90 days
- •following their participation in the study.
排除标准
- •ALL Patients:
- •1. Pregnant and/or breastfeeding women
- •2. Significant dermatologic findings relating to melanoma or premelanoma skin
- •lesions (excluding non-invasive basal or squamous cell lesion), determined as
- •part of a screening comprehensive skin evaluation performed by a qualified
- •dermatologist. Any concerning lesions identified during the screening period
- •will be biopsied and results known to be benign prior to enrollment. If the
- •pre-treatment biopsy results are of concern, the patient may need to be
- •excluded from the trial.
- •3. Patient is, in the opinion of the Study Investigator, not suitable to
- •participate in the trial.
- •4. Current, clinically significant disease, if severe enough to interfere with
- •the study and/or would confound the results. Any such patients should be
- •discussed with the Sponsor prior to enrollment in the trial
- •5. Diagnosis of schizophrenia, bipolar disorder, personality disorder or other
- •Diagnostic and Statistical Manual of Mental Disorders (DSM-III) disorders that
- •the investigator believes will interfere significantly with trial compliance.
- •6. A Patient Health Questionnaire-9 (PHQ-9) score of >= 15.
- •7. Any suicidal ideation of type 4 or 5 on the Columbia Suicide Severity Rating
- •Scale (C-SSRS). Any lifetime history of a suicide attempt, or any suicidal
- •behavior in the last month.
- •Note: Patients who are unable to complete the PHQ-9 or C-SSRS due to
- •significant neurocognitive defects may be enrolled in the study, as long as in
- •the opinion of the Primary Investigator there are no clinical signs or symptoms
- •of suicidal behavior since the last visit in the index study.
- •8. History of significant liver disease or liver injury, or a current liver
- •assessment due to abnormal liver tests (as indicated by abnormal liver function
- •tests, alanine transaminase [ALT], aspartate transaminase [AST], alkaline
- •phosphatase, or serum bilirubin >1.5× the upper limit of 4 normal [ULN] for any
- •of these tests) for an etiology other than nonalcoholic fatty liver disease
- •(NAFLD). Thus, any underlying etiology besides NAFLD, including diagnosed
- •non-alcoholic steatohepatitis (NASH), other causes of hepatitis, or history of
- •hepatic cirrhosis is exclusionary, but the presence of NAFLD is not be
- •exclusionary.
- •9. Severe renal dysfunction as defined by a glomerular filtration rate (GFR)
- •<30 mL/min/1.73 m2 in patiënts >12 years of age.
- •10. History or close family history (parents or siblings) of skin cancer or
- •melanoma (not including non-invasive/infiltrative basal or squamous cell
- •lesion) or patient history of ocularcutaneous albinism.
研究者
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