Comparison · NCT05130047-sae
Aldafermin (NGM282) vs Placebo: serious adverse events
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. Aldafermin (NGM282) vs Placebo: serious adverse events. Trial comparisons, record NCT05130047-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05130047-sae
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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 | 0.0667 | 0.0119 | 0.298 | wilson | |
| Risk in group 2 | 0 | 0 | 0.204 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0667 | -0.144 | 0.298 | 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 harm, for one more participant with a serious adverse event on Aldafermin (NGM282) than on Placebo | 15 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Aldafermin (NGM282) | Aldafermin (NGM282) is an investigational medication. It is an engineered analog of FGF-19 which reduces synthesis of bile acids and diarrhea caused by elevated bile acids. Participants received aldafermin (NGM282) 1 mg given by subcutaneous injection once daily for 28 days.~Aldafermin: 1 mg solution | 1 | 15 | EG000 |
| Group 2 | Placebo | A placebo looks exactly like the study drug but contains no active ingredients. It is used to learn if the effects seen are truly from the study drug. Participants received placebo solution matching aldafermin (NGM282) given by subcutaneous injection once daily for 28 days.~Placebo: Aldafermin placebo solution | 0 | 15 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse Events were collected from baseline to end of study for each participant, approximately 28 days
Source ClinicalTrials.gov
Trial
- Title
- Aldafermin (NGM282) for Chronic Diarrhea Due to Bile Acid Malabsorption (BAM)
- NCT number
- NCT05130047
- Phases
- PHASE2
- Conditions
- Chronic Diarrhea, Irritable Bowel Syndrome With Diarrhea, Bile Acid Malabsorption, Bile Acid Diarrhea, Bile Acid Malabsorption Syndrome Type II, Functional Diarrhea
- Interventions
- Aldafermin, Placebo
- Lead sponsor
- Michael Camilleri, MD
- Results first posted
- 2023-10-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05130047?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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