NCT03746522Phase 3Completed

Setmelanotide (RM-493), Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Participants With Moderate to Severe 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 completion2020-11-16Actual

Enrollment · participants52Actual

Source updated2023-12-01Last 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 (BBS); Alström Syndrome (AS)

Treatments or interventions studied

SetmelanotideDrugAlso known as SET, RM-493
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Percentage of Participants (≥12 Years of Age at Baseline) Who Reached ≥10% Weight Loss Threshold After 1 Year (Period 2): Pivotal Cohort; description: The percentage of participants (≥12 years of age at baseline) who achieved a ≥10% reduction from baseline in body weight at Period 2 or after 52 weeks of treatment with setmelanotide were analyzed. There was a 14-week placebo-controlled period at the beginning of the trial. After completion of the placebo-controlled period, all participants from the placebo group switched to setmelanotide treatment. The placebo group was integrated into the 52-week analysis so that the participants who received placebo, had 52 weeks of setmelanotide treatment after the first dose of "active" treatment. Placebo participants were also included in this analysis.; timeFrame: 52 weeks

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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