Skip to content

Trial · Interventional

CompletedPhase 2Registry data

Setmelanotide in a Single Patient With Partial Lipodystrophy

NCTNCT03262610 (opens ClinicalTrials.gov in a new tab)Other idRM-493-019
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
1 participants (actual)
Sponsor
Rhythm Pharmaceuticals, Inc. · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
15 Aug 2017
Primary completion
31 Jan 2018
Completion
31 Jan 2018
First posted
25 Aug 2017
Last update posted
4 Jan 2022
Conditions
Hypertriglyceridemia · Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201720182019
  1. Ph 2

    Setmelanotide in a Single Patient With Partial Lipodystrophy

    NCT03262610

    15 Aug 2017 to 31 Jan 2018

Registry summary

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

The objective of this single patient study is to assess the safety and efficacy of setmelanotide as a treatment of severe metabolic abnormalities resulting from LD, especially refractory hypertriglyceridemia leading to recurrent bouts of pancreatitis.

Interventions

  • SetmelanotideDrug

Arms1

  • Experimental

    Setmelanotide daily subcutaneous injection

    Up to 18 weeks setmelanotide treatment.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Fasting Triglycerides (TG) levels

    Time frame · 12 to 20 weeks

    Registry description

    The mean change from baseline in fasting triglycerides after setmelanotide treatment.

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.

Completed trials do not always post results.

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
Female
Age
from 15 Years up to 15 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Signed written informed consent 2. Ability to comply with visits and procedures required by program. 3. Has physician-confirmed partial lipodystrophy and the following characteristics: * Has atypical lipodystrophy. * Has presence of neutralizing antibody to metreleptin * Patient has life threatening hypertriglyceridemia and has had \>8 episodes of pancreatitis, requiring weekly plasmapheresis * Has Type 1 diabetes mellitus with HbA1c \> 10%. 4. Female, under the age of 18 years Exclusion Criteria: 1. 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 study compliance. Neurocognitive disorders affecting ability to consent will not be disqualifying as long as an appropriate guardian able to give consent has been appointed. 2. History or close family history (parents or siblings) of skin cancer or melanoma, or patient history of ocular-cutaneous albinism. 3. Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions, determined as part of a screening comprehensive skin evaluation performed by a qualified dermatologist. 4. Significant hypersensitivity to study drug. 5. Inability to comply with QD injection regimen.

PepBank is a research reference. Talk to a doctor before you use any peptide.