TrialPhase 2 Study to Evaluate Safety and Efficacy of RM-493 in Obese Participants
Trial details
- Registry ID
- NCT01749137
- Phase
- Phase 2
RYTM
Rhythm Pharmaceuticals, Inc.
Company identity checked against sources
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17Trials in this database
24Recorded changes · last 12 months
Partial coverageOnly the trials and history collected so far
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.
Completion dates · Pro
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Pro summarizes how far estimated completion dates moved later and counts trials with edits to their main study measures, using the history available here. View Pro features
Included trials
Check company identity sourcePhase 2 Trial to Evaluate Safety and Efficacy of Setmelanotide (RM-493) in Obese Participants With Prader-Willi Syndrome
Trial details
- Registry ID
- NCT02311673
- Phase
- Phase 2
Setmelanotide for the Treatment of Early-Onset Pro-Opiomelanocortin (POMC) Deficiency Obesity
Trial details
- Registry ID
- NCT02896192
- Phase
- Phase 3
Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity
Trial details
- Registry ID
- NCT03013543
- Phase
- Phase 2
Long Term Extension Trial of Setmelanotide
Trial details
- Registry ID
- NCT03651765
- Phase
- Phase 2, Phase 3
Setmelanotide (RM-493), Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Participants With Moderate to Severe Obesity
Trial details
- Registry ID
- NCT03746522
- Phase
- Phase 3
Open-Label Study of Setmelanotide in Hypothalamic Obesity
Trial details
- Registry ID
- NCT04725240
- Phase
- Phase 2
DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway
Trial details
- Registry ID
- NCT04963231
- Phase
- Phase 2
Setmelanotide in Pediatric Participants With Rare Genetic Diseases of Obesity
Trial details
- Registry ID
- NCT04966741
- Phase
- Phase 3
EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R Pathway
Trial details
- Registry ID
- NCT05093634
- Phase
- Phase 3
Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R Pathway
Trial details
- Registry ID
- NCT05194124
- Phase
- Phase 3
A Trial of Setmelanotide in Acquired Hypothalamic Obesity
Trial details
- Registry ID
- NCT05774756
- Phase
- Phase 3
A Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity
Trial details
- Registry ID
- NCT06046443
- Phase
- Phase 2
Open-Label Extension Study of Setmelanotide
Trial details
- Registry ID
- NCT06596135
- Phase
- Phase 3
A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)
Trial details
- Registry ID
- NCT06760546
- Phase
- Phase 3
A Study of Setmelanotide in Patients With Prader-Willi Syndrome
Trial details
- Registry ID
- NCT06772597
- Phase
- Phase 2
A Long-Term Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)
Trial details
- Registry ID
- NCT07156578
- Phase
- Phase 2
Latest recorded trial changes
EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R Pathway
NCT05093634 · Rhythm Pharmaceuticals, Inc.
Recruitment status
Recorded edit− Previous value
Active not recruiting
+ Updated value
Completed
Open-Label Extension Study of Setmelanotide
NCT06596135 · Rhythm Pharmaceuticals, Inc.
Participant count type
Recorded edit− Previous value
Estimated
+ Updated value
Actual
Enrollment · participant count
Recorded edit− Previous value
count: 30; type: ESTIMATED
+ Updated value
count: 28; type: ACTUAL
Completion date type
Recorded edit− Previous value
Estimated
+ Updated value
Actual
Primary completion date
Recorded edit− Previous value
2027-10-30
+ Updated value
2026-06-24
Recruitment status
Recorded edit− Previous value
Enrolling by invitation
+ Updated value
Completed
A Trial of Setmelanotide in Acquired Hypothalamic Obesity
NCT05774756 · Rhythm Pharmaceuticals, Inc.
Primary outcomes · main study measures
Text edit · unverified significance− Previous value
measure: Mean % change in BMI
+ Updated value
measure: Pivotal Cohort: Mean Percent Change From Baseline in Body Mass Index (BMI) After 52 Weeks on a Therapeutic Regimen
The saved outcome text may be shortened. Check the source for full wording.
Participant count type
Recorded edit− Previous value
Estimated
+ Updated value
Actual
Enrollment · participant count
Recorded edit− Previous value
count: 120; type: ESTIMATED
+ Updated value
count: 143; type: ACTUAL
A Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity
NCT06046443 · Rhythm Pharmaceuticals, Inc.
Participant count type
Recorded edit− Previous value
Estimated
+ Updated value
Actual
Completion date type
Recorded edit− Previous value
Estimated
+ Updated value
Actual
Primary completion date
Recorded edit− Previous value
2026-01-31
+ Updated value
2026-02-09
Recruitment status
Recorded edit− Previous value
Active not recruiting
+ Updated value
Completed
A Study of Setmelanotide in Patients With Prader-Willi Syndrome
NCT06772597 · Rhythm Pharmaceuticals, Inc.
Participant count type
Recorded edit− Previous value
Estimated
+ Updated value
Actual
Enrollment · participant count
Recorded edit− Previous value
count: 20; type: ESTIMATED
+ Updated value
count: 18; type: ACTUAL
Recruitment status
Recorded edit− Previous value
Recruiting
+ Updated value
Active not recruiting
A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)
NCT06760546 · Rhythm Pharmaceuticals, Inc.
Primary completion date
Recorded edit− Previous value
2026-09-30
+ Updated value
2027-03-13
EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R Pathway
NCT05093634 · Rhythm Pharmaceuticals, Inc.
Participant count type
Recorded edit− Previous value
Estimated
+ Updated value
Actual
Enrollment · participant count
Recorded edit− Previous value
count: 400; type: ESTIMATED
+ Updated value
count: 296; type: ACTUAL
Completion date type
Recorded edit− Previous value
Estimated
+ Updated value
Actual
Primary completion date
Recorded edit− Previous value
2025-12
+ Updated value
2025-12-22
A Long-Term Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)
NCT07156578 · Rhythm Pharmaceuticals, Inc.
Recruitment status
Recorded edit− Previous value
Not yet recruiting
+ Updated value
Enrolling by invitation
A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)
NCT06760546 · Rhythm Pharmaceuticals, Inc.
Primary completion date
Recorded edit− Previous value
2027-01-30
+ Updated value
2026-09-30
A Study of Setmelanotide in Patients With Prader-Willi Syndrome
NCT06772597 · Rhythm Pharmaceuticals, Inc.
Primary completion date
Recorded edit− Previous value
2026-01-31
+ Updated value
2026-10-31