Comparison · NCT02311673-bc1e5e46
Setmelanotide 1.5 mg (Open-Label Extension) vs Setmelanotide 2.5 mg (Open-Label Extension): Number of Participants With Clinically Significant Percent Change From Baseline in Body Fat Measured Using DEXA - Period 4
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Setmelanotide 1.5 mg (Open-Label Extension) vs Setmelanotide 2.5 mg (Open-Label Extension): Number of Participants With Clinically Significant Percent Change From Baseline in Body Fat Measured Using DEXA - Period 4. Trial comparisons, record NCT02311673-bc1e5e46. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02311673-bc1e5e46
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0 | 0.168 | wilson | |
| Risk in group 2 | 0 | 0 | 0.161 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.161 | 0.168 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Setmelanotide 1.5 mg (Open-Label Extension) | Participants received setmelanotide 1.5 mg once daily from Day 56 to Day 69 as a subcutaneous injection in an optional 2-week, open-label extension period. | 0 | 19 | OG000 |
| Group 2 | Setmelanotide 2.5 mg (Open-Label Extension) | Participants received setmelanotide 2.5 mg once daily from Day 56 to Day 69 as a subcutaneous injection in an optional 2-week, open-label extension period. | 0 | 20 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Clinically Significant Percent Change From Baseline in Body Fat Measured Using DEXA - Period 4
- Description
- Total body fat was assessed by DEXA scan. Number of participants with clinically significant percent change from baseline in body fat were judged by investigator.
- Time frame
- Baseline (Day 56) and Day 70
- Population
Participants in the FAS with available data were analyzed. In Period 4, one participant was randomized to setmelanotide 2.5 mg treatment group but treated with placebo. As participants in the FAS are classified based on randomized treatment group regardless of the actual treatment received, the placebo group is not included in the FAS analysis for Period 4.
Source ClinicalTrials.gov
Trial
- Title
- Phase 2 Trial to Evaluate Safety and Efficacy of Setmelanotide (RM-493) in Obese Participants With Prader-Willi Syndrome
- NCT number
- NCT02311673
- Phases
- PHASE2
- Conditions
- Prader-Willi Syndrome
- Interventions
- Setmelanotide, Placebo
- Lead sponsor
- Rhythm Pharmaceuticals, Inc.
- Results first posted
- 2023-07-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02311673?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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