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Trial · Interventional

Status unknownPhase 2Registry data

RM-493 Treatment Trial in Proopiomelanocortin (POMC) Deficient Patients

NCTNCT02507492 (opens ClinicalTrials.gov in a new tab)Other idRM-493-011Other id2014-002392-28Other id2014
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 2
Enrollment
10 participants (estimated)
Sponsor
Charite University, Berlin, Germany · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Germany

Start
Jan 2015
Primary completion
Jan 2018 (estimated)
Completion
Jul 2018 (estimated)
First posted
24 Jul 2015 (estimated)
Last update posted
22 Feb 2016 (estimated)
Conditions
Homozygous or Compound Heterozygous POMC, LEPR or PCSK1 Gene Mutation

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20152016201720182019
  1. Ph 2

    RM-493 Treatment Trial in Proopiomelanocortin (POMC) Deficient Patients

    NCT02507492

    Jan 2015 to est. Jul 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to evaluate the effects of a once daily subcutaneous (SC) injection of RM-493, in subjects with POMC (propiomelanocortin) or other related rare genetic mutations, on body weight, metabolic function and blood pressure. Patients who respond during the initial 84 days of treatment can enter into long-term (2-year) extensions. The study drug (RM-493) will be administered in an unblinded fashion.

Interventions

  • RM-493Drug

Arms1

  • Experimental

    RM-493 Once Daily

    Dose once daily in the morning

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Effect of RM-493 on Body weight

    Time frame · Day 1 through Day 84

    Registry description

    Change of body weight after Treatment with RM-493.

Secondary outcomes(5)

  1. Effect of RM-493 on metabolic serum parameters

    Time frame · Day 1 through Day 84

    Registry description

    Measurement of the effect of RM-493 on metabolic serum parameters as measured by blood test.

  2. Effect of RM-493 on blood pressure

    Time frame · Day 1 through Day 84

    Registry description

    Measurement of the effect of RM-493 on blood pressure by daily blood pressure measurements.

  3. Effect of RM-493 on hunger

    Time frame · Day 1 through Day 84

    Registry description

    Measurement of the effect of RM-493 on hunger as measured by the Global Hunger Scale

  4. Effect of RM-493 on body composition/Energy expenditure

    Time frame · Day 1 through Day 84

    Registry description

    Measurement of the effect of RM-493 on body composition/Energy expenditure

  5. Effect of RM-493 on weight loss after treatment continuation of 2 years

    Time frame · Day 1 through Day 730

    Registry description

    Measurement of the effect of RM-493 on weight loss after treatment continuation of 2 years

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Written informed consent * Homozygous or compound heterozygous (different gene mutation on both alleles) POMC, LEPR or PCSK1 gene mutation * Obesity (BMI \> 30 kg/m2; + 2 BMI SDS) * No other therapeutic option, which might cure the patient (e.g. bariatric surgery (see chapter 8)) * Negative Pregnancy test * Highly effective contraception in women (defined as pearl index \< 1), if necessary also for partners of test persons) * No participation in other clinical trials according to AMG (Arzneimittelgesetz) (2 months before and after) at the time of this trial * Normal or minimally elevated blood pressure (measured in 24RR monitoring or similar methods) according the guidelines of the ESH (European Society of Hypertension) and Deutsche Hochdruckliga: systolic \> 159 mmHg/diastolic 99 mmHg * sufficient kidney and liver function (Creatinine, ALT, AST) * normal values Alanine-Aminotransferase (ALT) (female): \< 31 U/l * normal values Alanine-Aminotransferase (ALT) (male): \< 41 U/l * normal values Aspartate-Aminotransferase (AST) (female \> 17 years): \< 35 U/l; (female \< 17 years): 16- 46 U/l * normal values Aspartate-Aminotransferase (AST) (male \> 17 years): \< 50 U/l; (male \< 17 years): 16-46 U/l * normal values bilirubins (male and female) up to 1,2 mg/dl * normal values Creatinine (female \> 15 years): 0,51-0,95 mg/dl) ; (female \< 15 years): 0,46-0,77 mg/dl * normal values Creatinine (male \> 15 years): 0,67 - 1,17 mg/dl) ; (male \< 15 years): 0,46-0,77 mg/dl Exclusion Criteria: * Pregnancy or Breastfeeding * All contraindications against study medication (including auxiliary substances) * Interactions with study medication * Participation of the patient in a clinical study within the last 2 months * Intolerance against albumin * Concomitant diseases, impaired organ functions, except for known, concurrent GI disorders or other clinical findings expected in PCSK1 or LEPR gene disorders * Renal insufficiency (Creatinine \> 0,95 mg/dl (female), \> 1,17 mg/dl (male)) * Impaired liver function (Bilirubins \> 1.2 mg/dl) * Neurological / psychiatric diseases * HIV Infection * Active Hepatitis B or C * Melanoma or Melanoma occurrence in the family history * Non-compliance * Subjects who are legally detained in an official institution

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