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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
213
RM-493 QD SC injection
Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment
Time frame: Baseline to Month 3
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE (also referred to as an adverse experience) could be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. TEAEs were defined as AEs reported after dosing on Day 1.
Time frame: From first dose up to Month 16
Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment
Time frame: Baseline, Month 3
Percent Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment
Time frame: Baseline, Month 3
Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
The mean change in daily hunger questionnaire scores for participants ≥ 12 years of age with obesity in treatment with setmelanotide was evaluated. On the Daily Hunger Questionnaire, each of the 3 items (average hunger in the last 24 hours, most/worst hunger in the last 24 hours, and morning hunger) was assessed daily and scored separately using a numeric rating score for each from 0 to 10, with 0 = not hungry at all and 10 = hungriest possible.
Time frame: Baseline, Month 3
Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
The mean change in daily hunger questionnaire scores for participants \< 12 years of age with obesity in treatment with setmelanotide was evaluated. Hunger was assessed daily using a Daily Hunger Questionnaire with a pictorial (smiley face) version of the Likert rating scale with scores ranged from 0 to 4, with 0 = not hungry at all and 4 = hungriest possible.
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Synexus Clinical Research US, Inc. - Simon Williamson Clinic, PC
Birmingham, Alabama, United States
Synexus Clinical Research US, Inc. - Phoenix Southeast
Chandler, Arizona, United States
Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC
Mesa, Arizona, United States
Honor Health Research Institute
Scottsdale, Arizona, United States
Axis Clinical Trials-Downtown
Los Angeles, California, United States
Axis Clinical Trials Headquarters
Los Angeles, California, United States
San Diego Wake Research
San Diego, California, United States
Anschutz Health and Wellness Center University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Division of Endocrinology and Diabetes Children's National Hospital
Washington D.C., District of Columbia, United States
University of Florida College of Medicine
Gainesville, Florida, United States
...and 48 more locations
Time frame: Baseline, Month 3
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
For participants ≥ 12 years of age, the following question was asked using the Global Hunger Questionnaire: Overall, how would you rate the hunger you experience now? Possible responses were: No hunger; Mild hunger; Moderate hunger; Severe hunger; and Not answered.
Time frame: Baseline, Month 3
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
For participants \< 12 years of age, the following question was asked to parents or caregivers of participants using the Global Hunger Questionnaire: How hungry is your child acting now? Possible responses were: Not hungry at all; A little hungry; Moderately hungry; Extremely hungry; and Not answered.
Time frame: Baseline, Month 3
Percent Change From Baseline in Waist Circumference After 3 Months of Setmelanotide Treatment
Waist circumference (cm) was measured according to the National Heart, Lung, and Blood Institute (NHLBI) criteria. All measurements were single measures. Waist circumference was measured when participants were in fasting condition and at approximately the same time at each visit.
Time frame: Baseline, Month 3