Trial · NCT04771273
A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)
NCT04771273, Phase 2, Completed, Boehringer Ingelheim; results first posted 2024-12-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3). Trials, record NCT04771273. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04771273
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)
- NCT number
- NCT04771273
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 295 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Non-alcoholic Steatohepatitis (NASH)
- Interventions
- Survodutide, Placebo
- First posted
- 2021-02-25
- Last updated
- 2024-12-03
- Other registries' IDs
- eudract:2020-002723-11
- Results first posted
- 2024-12-03
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Improvement (Yes/ no) From Baseline in Liver Histological Findings Based on Liver Biopsy After 48 Weeks of Treatment in Patients With NASH (NAS ≥ 4, Fibrosis F1-F3) - Actual Maintenance Treatment | At baseline and at 48 weeks. | Percentage of patients who had an improvement from baseline in liver histological findings based on liver biopsy after 48 weeks of treatment is reported. Percentages were rounded to one decimal place. Improvement in histological findings was defined as a composite of improvement in NASH and no worsening of fibrosis. Improvement in non-alcoholic steatohepatitis (NASH) was defined as decrease of at least 2 points in non-alcoholic fatty liver disease (NAFLD) activity score (NAS) with at least 1 point decrease in NAS subscore of either lobular inflammation or ballooning. The NAS represents the sum of subscores for steatosis (scored from 0-3), lobular inflammation (scored from 0-3) and ballooning (scored from 0-2), and the total score ranges from 0 to 8 with higher scores representing worsening of the disease. The total score for the fibrosis stage ranges from 0 to 4 with higher score indication worsening of the disease. Patients without post-baseline data were considered non-responders. |
| Primary | Improvement (Yes/ no) From Baseline in Liver Histological Findings Based on Liver Biopsy After 48 Weeks of Treatment in Patients With NASH (NAS ≥ 4, Fibrosis F1-F3) - Planned Maintenance Treatment | At baseline and after 48 weeks of treatment. | Percentage of patients who had an improvement from baseline in liver histological findings based on liver biopsy after 48 weeks of treatment is reported. Percentages were rounded to one decimal place. Improvement in histological findings was defined as a composite of improvement in non-alcoholic steatohepatitis (NASH) and no worsening of fibrosis. Improvement in NASH was defined as decrease of at least 2 points in non-alcoholic fatty liver disease (NAFLD) activity score (NAS) with at least 1 point decrease in NAS subscore of either lobular inflammation or ballooning. The NAS represents the sum of subscores for steatosis (scored from 0-3), lobular inflammation (scored from 0-3) and ballooning (scored from 0-2), and the total score ranges from 0 to 8 with higher scores representing worsening of the disease. The total score for the fibrosis stage ranges from 0 to 4 with higher score indication worsening of the disease. Patients without post-baseline data were considered non-responders. |
| Secondary | Improvement of Liver Fat Content (Yes/ no) Defined as at Least 30% Relative Reduction in Liver Fat Content After 48 Weeks of Treatment Compared to Baseline Assessed by MRI-PDFF - Actual Maintenance Treatment | At baseline and after 48 weeks. | Percentage of participants with improvement in liver fat content is reported. Improvement in liver fat content was defined as percentage reduction from baseline of ≥30% in liver fat content after 48 weeks of treatment compared to baseline. Percentages were rounded to one decimal place. Liver fat content was assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF). Patients without post-baseline values were imputed as non-responders. |
| Secondary | Improvement of Liver Fat Content (Yes/ no) Defined as at Least 30% Relative Reduction in Liver Fat Content After 48 Weeks of Treatment Compared to Baseline Assessed by MRI-PDFF - Planned Maintenance Treatment | At baseline and at 48 weeks. | Percentage of participants with improvement in liver fat content is reported. Improvement in liver fat content was defined as percentage reduction from baseline of ≥30% in liver fat content after 48 weeks of treatment compared to baseline. Liver fat content was assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF). Patients without post-baseline values were imputed as non-responders. |
| Secondary | Absolute Change of Liver Fat Content From Baseline After 48 Weeks of Treatment Assessed by MRI-PDFF - Actual Maintenance Treatment | MMRM included measurements from baseline and at Week 28 and at Week 48 after first drug administration. MMRM estimates of absolute change from baseline to Week 48 is reported. | Absolute change of liver fat content (percentage \[%\]) from baseline after 48 weeks of treatment is reported. Liver fat content was assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF). Least Squares Mean (Standard error) were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors. |
| Secondary | Absolute Change of Liver Fat Content From Baseline After 48 Weeks of Treatment Assessed by MRI-PDFF - Planned Maintenance Treatment | MMRM included measurements from baseline and at Week 28 and at Week 48 after first drug administration. MMRM estimates of absolute change from baseline to Week 48 is reported. | Absolute change of liver fat content from baseline after 48 weeks of treatment is reported. Liver fat content was assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF). Least Squares Mean (Standard error) were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors. |
| Secondary | Percent Change of Liver Fat Content From Baseline After 48 Weeks of Treatment Assessed by MRI-PDFF - Actual Maintenance Treatment | MMRM included measurements from baseline and at Week 28 and at Week 48 after first drug administration. MMRM estimates of percent change from baseline to Week 48 is reported. | Percent change of liver fat content (percentage \[%\]) from baseline after 48 weeks of treatment is reported. Liver fat content was assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF). Least Squares Mean (Standard error) were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors. |
| Secondary | Percent Change of Liver Fat Content From Baseline After 48 Weeks of Treatment Assessed by MRI-PDFF - Planned Maintenance Treatment | MMRM included measurements from baseline and at Week 28 and at Week 48 after first drug administration. MMRM estimates of percent change from baseline to Week 48 is reported. | Percent change of liver fat content (percentage \[%\]) from baseline after 48 weeks of treatment is reported. Liver fat content was assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF). Least Squares Mean (Standard error) were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors. |
| Secondary | Improvement of Fibrosis (Yes/ no) Defined as at Least One Stage Decrease in Fibrosis Stage After 48 Weeks of Treatment Assessed by Liver Biopsy - Actual Maintenance Treatment | At baseline and after 48 weeks of treatment. | Percentage of participants with improvement of liver fibrosis is reported. Improvement of fibrosis was defined as at least one stage decrease in fibrosis stage after 48 weeks of treatment assessed by liver biopsy. The total score for the fibrosis stage ranges from 0 to 4 with higher score indication worsening of the disease and the stages of fibrosis based on their location are the following: * 1A Zone 3, perisinusoidal, delicate; * 1B Zone 3, perisinusoidal, dense; * 1C Portal, periportal only; * 2 Zone 3, perisinusoidal + portal, periportal only; * 3 Bridging fibrosis; * 4 Cirrhosis. For analysis purposes no distinction was made between stages 1A, 1B and 1C. |
| Secondary | Improvement of Fibrosis (Yes/ no) Defined as at Least One Stage Decrease in Fibrosis Stage After 48 Weeks of Treatment Assessed by Liver Biopsy - Planned Maintenance Treatment | At baseline and after 48 weeks of treatment. | Percentage of participants with improvement of liver fibrosis is reported. Improvement of fibrosis was defined as at least one stage decrease in fibrosis stage after 48 weeks of treatment assessed by liver biopsy. The total score for the fibrosis stage ranges from 0 to 4 with higher score indication worsening of the disease and the stages of fibrosis based on their location are the following: * 1A Zone 3, perisinusoidal, delicate; * 1B Zone 3, perisinusoidal, dense; * 1C Portal, periportal only; * 2 Zone 3, perisinusoidal + portal, periportal only; * 3 Bridging fibrosis; * 4 Cirrhosis. For analysis purposes no distinction was made between stages 1A, 1B and 1C. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Improvement (Yes/ no) From Baseline in Liver Histological Findings Based on Liver Biopsy After 48 Weeks of Treatment in Patients With NASH (NAS ≥ 4, Fibrosis F1-F3) - Actual Maintenance Treatment | At baseline and at 48 weeks. | Treated set - actual maintenance treatment. Patients are analyzed according to the actual treatment they received at the start of the dose maintenance period (for patients who reached the maintenance period) or the next maintenance dose up from the dose at treatment discontinuation (for patients who discontinued treatment prior to the maintenance period). | Percentage of participants | NUMBER |
| PRIMARY | Improvement (Yes/ no) From Baseline in Liver Histological Findings Based on Liver Biopsy After 48 Weeks of Treatment in Patients With NASH (NAS ≥ 4, Fibrosis F1-F3) - Planned Maintenance Treatment | At baseline and after 48 weeks of treatment. | Treated set - planned maintenance treatment: included all patients that were administered survodutide or placebo matching survodutide. Patients are analyzed for this endpoint according to the planned treatment (planned maintenance dose strength) they were assigned at randomisation even if patients did not reach the maintenance period at all, and therefore did not settle on any maintenance dose. | percentage of participants | NUMBER |
| SECONDARY | Improvement of Liver Fat Content (Yes/ no) Defined as at Least 30% Relative Reduction in Liver Fat Content After 48 Weeks of Treatment Compared to Baseline Assessed by MRI-PDFF - Actual Maintenance Treatment | At baseline and after 48 weeks. | Treated set - actual maintenance treatment. Patients are analyzed according to the actual treatment they received at the start of the dose maintenance period (for patients who reached the maintenance period) or the next maintenance dose up from the dose at treatment discontinuation (for patients who discontinued treatment prior to the maintenance period). | Percentage of participants | NUMBER |
| SECONDARY | Improvement of Liver Fat Content (Yes/ no) Defined as at Least 30% Relative Reduction in Liver Fat Content After 48 Weeks of Treatment Compared to Baseline Assessed by MRI-PDFF - Planned Maintenance Treatment | At baseline and at 48 weeks. | Treated set - planned maintenance treatment: included all patients that were administered survodutide or placebo matching survodutide. Patients are analyzed for this endpoint according to the planned treatment (planned maintenance dose strength) they were assigned at randomisation even if patients did not reach the maintenance period at all, and therefore did not settle on any maintenance dose. | Percentage of participants | NUMBER |
| SECONDARY | Absolute Change of Liver Fat Content From Baseline After 48 Weeks of Treatment Assessed by MRI-PDFF - Actual Maintenance Treatment | MMRM included measurements from baseline and at Week 28 and at Week 48 after first drug administration. MMRM estimates of absolute change from baseline to Week 48 is reported. | Treated set - actual maintenance treatment. Patients are analyzed according to the actual treatment they received at the start of the dose maintenance period (for patients who reached the maintenance period) or the next maintenance dose up from the dose at treatment discontinuation (for patients who discontinued treatment prior to the maintenance period). The reported number of participants analyzed reflects the number of participants in the analysis model. | percentage of liver fat content | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change of Liver Fat Content From Baseline After 48 Weeks of Treatment Assessed by MRI-PDFF - Planned Maintenance Treatment | MMRM included measurements from baseline and at Week 28 and at Week 48 after first drug administration. MMRM estimates of absolute change from baseline to Week 48 is reported. | Treated set - planned maintenance treatment. Patients are analyzed for this endpoint according to the planned treatment (planned maintenance dose strength) they were assigned at randomisation even if patients did not reach the maintenance period at all, and therefore did not settle on any maintenance dose. The reported number of participants analyzed reflects the number of participants in the analysis model. | percentage of liver fat content | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change of Liver Fat Content From Baseline After 48 Weeks of Treatment Assessed by MRI-PDFF - Actual Maintenance Treatment | MMRM included measurements from baseline and at Week 28 and at Week 48 after first drug administration. MMRM estimates of percent change from baseline to Week 48 is reported. | Treated set - actual maintenance treatment. Patients are analyzed according to the actual treatment they received at the start of the dose maintenance period (for patients who reached the maintenance period) or the next maintenance dose up from the dose at treatment discontinuation (for patients who discontinued treatment prior to the maintenance period). The reported number of participants analyzed reflects the number of participants in the analysis model. | percent change of liver fat content | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change of Liver Fat Content From Baseline After 48 Weeks of Treatment Assessed by MRI-PDFF - Planned Maintenance Treatment | MMRM included measurements from baseline and at Week 28 and at Week 48 after first drug administration. MMRM estimates of percent change from baseline to Week 48 is reported. | Treated set - planned maintenance treatment: all patients that administered survodutide or placebo matching survodutide. Patients are analyzed for this endpoint according to the planned treatment (planned maintenance dose strength) they were assigned at randomisation even if patients did not reach the maintenance period at all, and therefore did not settle on any maintenance dose.~The reported number of participants analyzed reflects the number of participants in the analysis model. | percent change of liver fat content | LEAST_SQUARES_MEAN |
| SECONDARY | Improvement of Fibrosis (Yes/ no) Defined as at Least One Stage Decrease in Fibrosis Stage After 48 Weeks of Treatment Assessed by Liver Biopsy - Actual Maintenance Treatment | At baseline and after 48 weeks of treatment. | Treated set - actual maintenance treatment. Patients are analyzed according to the actual treatment they received at the start of the dose maintenance period (for patients who reached the maintenance period) or the next maintenance dose up from the dose at treatment discontinuation (for patients who discontinued treatment prior to the maintenance period). | Percentage of participants | NUMBER |
| SECONDARY | Improvement of Fibrosis (Yes/ no) Defined as at Least One Stage Decrease in Fibrosis Stage After 48 Weeks of Treatment Assessed by Liver Biopsy - Planned Maintenance Treatment | At baseline and after 48 weeks of treatment. | Treated set - planned maintenance treatment: included all patients that were administered survodutide or placebo matching survodutide. Patients are analyzed for this endpoint according to the planned treatment (planned maintenance dose strength) they were assigned at randomisation even if patients did not reach the maintenance period at all, and therefore did not settle on any maintenance dose. | Percentage of participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Improvement (Yes/ no) From Baseline in Liver Histological Findings Based on Liver Biopsy After 48 Weeks of Treatment in Patients With NASH (NAS ≥ 4, Fibrosis F1-F3) - Actual Maintenance Treatment | Survodutide 2.4 mg - Actual Maintenance Treatment | 38.7 | Percentage of participants | ||
| Improvement (Yes/ no) From Baseline in Liver Histological Findings Based on Liver Biopsy After 48 Weeks of Treatment in Patients With NASH (NAS ≥ 4, Fibrosis F1-F3) - Actual Maintenance Treatment | Survodutide 4.8 mg - Actual Maintenance Treatment | 63.8 | Percentage of participants | ||
| Improvement (Yes/ no) From Baseline in Liver Histological Findings Based on Liver Biopsy After 48 Weeks of Treatment in Patients With NASH (NAS ≥ 4, Fibrosis F1-F3) - Actual Maintenance Treatment | Survodutide 6.0 mg - Actual Maintenance Treatment | 55.8 | Percentage of participants | ||
| Improvement (Yes/ no) From Baseline in Liver Histological Findings Based on Liver Biopsy After 48 Weeks of Treatment in Patients With NASH (NAS ≥ 4, Fibrosis F1-F3) - Actual Maintenance Treatment | Placebo - Actual Maintenance Treatment | 15.2 | Percentage of participants | ||
| Improvement (Yes/ no) From Baseline in Liver Histological Findings Based on Liver Biopsy After 48 Weeks of Treatment in Patients With NASH (NAS ≥ 4, Fibrosis F1-F3) - Planned Maintenance Treatment | Survodutide 2.4 mg - Planned Maintenance Treatment | 46.6 | percentage of participants | ||
| Improvement (Yes/ no) From Baseline in Liver Histological Findings Based on Liver Biopsy After 48 Weeks of Treatment in Patients With NASH (NAS ≥ 4, Fibrosis F1-F3) - Planned Maintenance Treatment | Survodutide 4.8 mg - Planned Maintenance Treatment | 62.5 | percentage of participants | ||
| Improvement (Yes/ no) From Baseline in Liver Histological Findings Based on Liver Biopsy After 48 Weeks of Treatment in Patients With NASH (NAS ≥ 4, Fibrosis F1-F3) - Planned Maintenance Treatment | Survodutide 6.0 mg - Planned Maintenance Treatment | 43.2 | percentage of participants | ||
| Improvement (Yes/ no) From Baseline in Liver Histological Findings Based on Liver Biopsy After 48 Weeks of Treatment in Patients With NASH (NAS ≥ 4, Fibrosis F1-F3) - Planned Maintenance Treatment | Placebo - Planned Maintenance Treatment | 13.5 | percentage of participants | ||
Improvement of Liver Fat Content (Yes/ no) Defined as at Least 30% Relative Reduction in Liver Fat Content After 48 Weeks of Treatment Compared to Baseline Assessed by MRI-PDFF - Actual Maintenance Treatment | Survodutide 2.4 mg - Actual Maintenance Treatment | 50.5 | Percentage of participants | ||
Improvement of Liver Fat Content (Yes/ no) Defined as at Least 30% Relative Reduction in Liver Fat Content After 48 Weeks of Treatment Compared to Baseline Assessed by MRI-PDFF - Actual Maintenance Treatment | Survodutide 4.8 mg - Actual Maintenance Treatment | 66.7 | Percentage of participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Escalation Period | STARTED | Survodutide 2.4 mg - Planned Maintenance Treatment | 73 | |
| Dose Escalation Period | STARTED | Survodutide 4.8 mg - Planned Maintenance Treatment | 73 | |
| Dose Escalation Period | STARTED | Survodutide 6.0 mg - Planned Maintenance Treatment | 75 | |
| Dose Escalation Period | STARTED | Placebo - Planned Maintenance Treatment | 74 | |
| Dose Escalation Period | Treated With Trial Medication | Survodutide 2.4 mg - Planned Maintenance Treatment | 73 | |
| Dose Escalation Period | Treated With Trial Medication | Survodutide 4.8 mg - Planned Maintenance Treatment | 72 | |
| Dose Escalation Period | Treated With Trial Medication | Survodutide 6.0 mg - Planned Maintenance Treatment | 74 | |
| Dose Escalation Period | Treated With Trial Medication | Placebo - Planned Maintenance Treatment | 74 | |
| Dose Escalation Period | COMPLETED | Survodutide 2.4 mg - Planned Maintenance Treatment | 62 | |
| Dose Escalation Period | COMPLETED | Survodutide 4.8 mg - Planned Maintenance Treatment | 63 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events292
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Survodutide 2.4 mg - Actual Maintenance Treatment | 1 | 93 | |
| other | Anaemia | Blood and lymphatic system disorders | Survodutide 4.8 mg - Actual Maintenance Treatment | 2 | 69 | |
| other | Anaemia | Blood and lymphatic system disorders | Survodutide 6.0 mg - Actual Maintenance Treatment | 1 | 52 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo - Actual Maintenance Treatment | 5 | 79 | |
| other | Abdominal distension | Gastrointestinal disorders | Survodutide 2.4 mg - Actual Maintenance Treatment | 15 | 93 | |
| other | Abdominal distension | Gastrointestinal disorders | Survodutide 4.8 mg - Actual Maintenance Treatment | 10 | 69 | |
| other | Abdominal distension | Gastrointestinal disorders | Survodutide 6.0 mg - Actual Maintenance Treatment | 9 | 52 | |
| other | Abdominal distension | Gastrointestinal disorders | Placebo - Actual Maintenance Treatment | 7 | 79 | |
| other | Abdominal pain | Gastrointestinal disorders | Survodutide 2.4 mg - Actual Maintenance Treatment | 12 | 93 | |
| other | Abdominal pain | Gastrointestinal disorders | Survodutide 4.8 mg - Actual Maintenance Treatment | 5 | 69 |
1 to 10 of 292Source ClinicalTrials.gov
See all 292 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Survodutide 2.4 mg - Actual Maintenance Treatment | 0 | 93 |
| Total, all-cause mortality | Survodutide 4.8 mg - Actual Maintenance Treatment | 0 | 69 |
| Total, all-cause mortality | Survodutide 6.0 mg - Actual Maintenance Treatment | 0 | 52 |
| Total, all-cause mortality | Placebo - Actual Maintenance Treatment | 0 | 79 |
| Total, other adverse events | Survodutide 2.4 mg - Actual Maintenance Treatment | 85 | 93 |
| Total, other adverse events | Survodutide 4.8 mg - Actual Maintenance Treatment | 60 | 69 |
| Total, other adverse events | Survodutide 6.0 mg - Actual Maintenance Treatment | 49 | 52 |
| Total, other adverse events | Placebo - Actual Maintenance Treatment | 68 | 79 |
| Total, serious adverse events | Survodutide 2.4 mg - Actual Maintenance Treatment | 5 | 93 |
| Total, serious adverse events | Survodutide 4.8 mg - Actual Maintenance Treatment | 7 | 69 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38847460 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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