NCT04966741Phase 3Completed

Setmelanotide in Pediatric Participants With Rare Genetic Diseases of Obesity

Study sponsor: Rhythm Pharmaceuticals, Inc. · RYTM

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-09-18Actual

Enrollment · participants12Actual

Source updated2024-11-27Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Bardet-Biedl Syndrome; POMC Deficiency Obesity; PCSK1 Deficiency Obesity; LEPR Deficiency Obesity

Treatments or interventions studied

SetmelanotideDrugAlso known as IMCIVREE

Primary outcomes · main study measures

Read the study measures

measure: Percentage of Participants With Greater Than or Equal to (≥) 0.2 Reduction of BMI Z-Score From Baseline to Week 52; description: A "responder" was defined as a decrease from baseline to 52 weeks in the participant's BMI z-score of ≥0.2. BMI was calculated using participant's weight and height assessments, using the following formula: BMI = kg/m\^2. The BMI Z-scores were based on the World Health Organization's Child Growth Standards 2007 and indicated the number of standard deviations away from the mean. A Z-score of 0 was equal to the mean of a reference population (i.e., healthy, age and sex-matched individuals). A decrease of BMI Z-score (\< 0) indicated a reduction in BMI from Baseline whereas an increase of BMI-Z score (\> 0) indicated an increase in BMI from Baseline. Baseline was defined as the most recent measurement prior to the first administration of study drug.; timeFrame: Baseline up to Week 52; measure: Mean Percent Change From Baseline in BMI; description: Mean percent change from baseline to Week 52 in BMI was reported. BMI was calculated using participant's weight and height assessments, using the following formula: BMI = kg/m\^2. Baseline was defined as the most recent measurement prior to the first administration of study drug.; timeFrame: Baseline, Week 52

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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