Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity (NCT03013543) | Clinical Trial Compass
CompletedPhase 2
Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity
United States213 participantsStarted 2017-02-10
Plain-language summary
The purpose of the study was to determine the effect of setmelanotide (RM-493) on weight, hunger assessments, and other factors in participants with rare genetic disorders of obesity.
Who can participate
Age range6 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Participants with the following genotypes and/or clinical assessment:
ā. POMC/PCSK1/LEPR heterozygous - not currently enrolling new participants
ā. POMC/PCSK1/LEPR compound heterozygous (two different mutations in gene) or homozygous deficiency obesity
ā. POMC/PCSK1/LEPR composite heterozygous (two or more mutations in two or more genes) deficiency obesity
ā. SMS
ā. SH2B1 deficiency obesity
ā. Chromosomal rearrangement of the 16p11.2 locus causing obesity
ā. Carboxypeptidase E (CPE) compound heterozygous or homozygous deficiency obesity
Exclusion criteria
ā. Recent intensive (within 2 months) diet and/or exercise regimen with or without the use of weight loss agents that has resulted in \> 2% weight loss.
ā. Use of any medication that is approved to treat obesity within three months of first dose of study drug (e.g., orlistat, lorcaserin, phentermine-topiramate, naltrexone-bupropion).
ā. Gastric bypass surgery within the previous six months or any prior gastric bypass surgery resulting in \>10% weight loss durably maintained
ā. Diagnosis of schizophrenia, bipolar disorder, personality disorder, major depressive disorder, or other psychiatric disorder(s)
What they're measuring
1
Number of Participants With ā„ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment