Trial · NCT04667377
A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight
NCT04667377, Phase 2, Completed, Boehringer Ingelheim; results first posted 2023-11-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight. Trials, record NCT04667377. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04667377
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight
- NCT number
- NCT04667377
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 387 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Obesity
- Interventions
- BI 456906, Placebo
- First posted
- 2020-12-14
- Last updated
- 2023-11-02
- Other registries' IDs
- eudract:2020-002479-37
- Results first posted
- 2023-11-02
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change in Body Weight From Baseline to Week 46 | Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46. | Percentage change in body weight from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit (Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46) as repeated measures, an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. For analysis, all available post-baseline body weight measurements (on- and off-treatment) were used, except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used. That is, a hypothetical strategy was used for intercurrent event (ICE) "COVID-19 pandemic-related early treatment discontinuation", a treatment policy strategy for ICE "non-pandemic-related early treatment discontinuation". |
| Secondary | Weight Loss of ≥ 5% of Baseline Weight at Week 46 | At baseline and at Week 46. | Weight loss of greater than or equal to 5 percent (≥5%) of baseline weight at Week 46 (yes/no), reported as percentage of participants who achieved a weight loss of ≥5% of baseline weight at Week 46. For analysis, all available post-baseline body weight measurements (on- and off-treatment) were used, except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used. Percentages were rounded to one decimal place. |
| Secondary | Weight Loss of ≥ 10% of Baseline Weight at Week 46 | At baseline and at Week 46. | Weight loss of greater than or equal to 10 percent (≥10%) of baseline weight at Week 46 (yes/no), reported as percentage of participants who achieved a weight loss of ≥10% of baseline weight at Week 46. For analysis, all available post-baseline body weight measurements (on- and off-treatment) were used, except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used. Percentages were rounded to one decimal place. |
| Secondary | Weight Loss of ≥ 15% of Baseline Weight at Week 46 | At baseline and at Week 46. | Weight loss of greater than or equal to 15 percent (≥15%) of baseline weight at Week 46 (yes/no), reported as percentage of participants who achieved a weight loss of ≥15% of baseline weight at Week 46. For analysis, all available post-baseline body weight measurements (on- and off-treatment) were used, except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used. Percentages were rounded to one decimal place. |
| Secondary | Absolute Change in Body Weight From Baseline to Week 46 | Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46. | Absolute change in body weight from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit (Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46) as repeated measures and an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. MMRM analysis was performed on the FAS, using planned maintenance treatment (dose assigned at randomisation) and including only on-treatment data, regardless of whether early treatment discontinuation was COVID-19 related. |
| Secondary | Absolute Change in Waist Circumference From Baseline to Week 46 | Baseline, Week 6, 12, 18, 24, 32, 40, and 46. | Absolute change in waist circumference from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline waist circumference as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit (Week 6, 12, 18, 24, 32, 40, and 46) as repeated measures and an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. MMRM analysis was performed on the FAS, using planned maintenance treatment (dose assigned at randomisation) and including only on-treatment data, regardless of whether early treatment discontinuation was COVID-19 related. |
| Secondary | Absolute Change in Systolic Blood Pressure From Baseline to Week 46 | Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46. | Absolute change in systolic blood pressure from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline systolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46) as repeated measures and an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. MMRM analysis was performed on the FAS, using planned maintenance treatment (dose assigned at randomisation) and including only on-treatment data, regardless of whether early treatment discontinuation was COVID-19 related. |
| Secondary | Absolute Change in Diastolic Blood Pressure From Baseline to Week 46 | Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46. | Absolute change in diastolic blood pressure from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline diastolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46) as repeated measures and an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. MMRM analysis was performed on the FAS, using planned maintenance treatment (dose assigned at randomisation) and including only on-treatment data, regardless of whether early treatment discontinuation was COVID-19 related. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Change in Body Weight From Baseline to Week 46 | Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46. | Full analysis set (all randomised participants who received at least one dose of study treatment and who have analysable data for at least one efficacy endpoint) using planned maintenance treatment. Number of participants analysed = Participants with available data for the outcome measure. | Percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Weight Loss of ≥ 5% of Baseline Weight at Week 46 | At baseline and at Week 46. | Full analysis set (all randomised participants who received at least one dose of study treatment and who have analysable data for at least one efficacy endpoint) using planned maintenance treatment. Number of participants analysed = Participants with available data for the outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Weight Loss of ≥ 10% of Baseline Weight at Week 46 | At baseline and at Week 46. | Full analysis set (all randomised participants who received at least one dose of study treatment and who have analysable data for at least one efficacy endpoint) using planned maintenance treatment. Number of participants analysed = Participants with available data for the outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Weight Loss of ≥ 15% of Baseline Weight at Week 46 | At baseline and at Week 46. | Full analysis set (all randomised participants who received at least one dose of study treatment and who have analysable data for at least one efficacy endpoint) using planned maintenance treatment. Number of participants analysed = Participants with available data for the outcome measure. | Percentage of particpants | NUMBER |
| SECONDARY | Absolute Change in Body Weight From Baseline to Week 46 | Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46. | Full analysis set (FAS, all randomised participants who received at least one dose of study treatment and who have analysable data for at least one efficacy endpoint), using planned maintenance treatment. Number of participants analysed = Participants with available data for the outcome measure. | Kilogram (kg) | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change in Waist Circumference From Baseline to Week 46 | Baseline, Week 6, 12, 18, 24, 32, 40, and 46. | Full analysis set (FAS, all randomised participants who received at least one dose of study treatment and who have analysable data for at least one efficacy endpoint), using planned maintenance treatment. Number of participants analysed = Participants with available data for the outcome measure. | Centimeter (cm) | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change in Systolic Blood Pressure From Baseline to Week 46 | Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46. | Full analysis set (FAS, all randomised participants who received at least one dose of study treatment and who have analysable data for at least one efficacy endpoint), using planned maintenance treatment. Number of participants analysed = Participants with available data for the outcome measure. | Millimeter of mercury (mmHg) | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change in Diastolic Blood Pressure From Baseline to Week 46 | Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46. | Full analysis set (FAS, all randomised participants who received at least one dose of study treatment and who have analysable data for at least one efficacy endpoint), using planned maintenance treatment. Number of participants analysed = Participants with available data for the outcome measure. | Millimeter of mercury (mmHg) | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Change in Body Weight From Baseline to Week 46 | 0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation) | -6.19 | Standard Error 1.07 | Percentage change | |
| Percentage Change in Body Weight From Baseline to Week 46 | 2.4 mg BI 456906 - Planned Maintenance Treatment | -12.51 | Standard Error 1.01 | Percentage change | |
| Percentage Change in Body Weight From Baseline to Week 46 | 3.6 mg BI 456906 - Planned Maintenance Treatment | -13.22 | Standard Error 1.04 | Percentage change | |
| Percentage Change in Body Weight From Baseline to Week 46 | 4.8 mg BI 456906 - Planned Maintenance Treatment | -14.94 | Standard Error 1.01 | Percentage change | |
| Percentage Change in Body Weight From Baseline to Week 46 | Placebo | -2.82 | Standard Error 1.06 | Percentage change | |
| Weight Loss of ≥ 5% of Baseline Weight at Week 46 | 0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation) | 60.7 | Percentage of participants | ||
| Weight Loss of ≥ 5% of Baseline Weight at Week 46 | 2.4 mg BI 456906 - Planned Maintenance Treatment | 81.0 | Percentage of participants | ||
| Weight Loss of ≥ 5% of Baseline Weight at Week 46 | 3.6 mg BI 456906 - Planned Maintenance Treatment | 82.0 | Percentage of participants | ||
| Weight Loss of ≥ 5% of Baseline Weight at Week 46 | 4.8 mg BI 456906 - Planned Maintenance Treatment | 82.8 | Percentage of participants | ||
| Weight Loss of ≥ 5% of Baseline Weight at Week 46 | Placebo | 25.9 | Percentage of participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow35
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Escalation Period | STARTED | 0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation) | 78 | |
| Dose Escalation Period | STARTED | 2.4 mg BI 456906 - Planned Maintenance Treatment | 78 | |
| Dose Escalation Period | STARTED | 3.6 mg BI 456906 - Planned Maintenance Treatment | 77 | |
| Dose Escalation Period | STARTED | 4.8 mg BI 456906 - Planned Maintenance Treatment | 77 | |
| Dose Escalation Period | STARTED | Placebo | 77 | |
| Dose Escalation Period | Treated During Dose Escalation Period | 0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation) | 77 | |
| Dose Escalation Period | Treated During Dose Escalation Period | 2.4 mg BI 456906 - Planned Maintenance Treatment | 78 | |
| Dose Escalation Period | Treated During Dose Escalation Period | 3.6 mg BI 456906 - Planned Maintenance Treatment | 77 | |
| Dose Escalation Period | Treated During Dose Escalation Period | 4.8 mg BI 456906 - Planned Maintenance Treatment | 77 | |
| Dose Escalation Period | Treated During Dose Escalation Period | Placebo | 77 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 participant flowAdverse events230
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 | Abdominal distension | Gastrointestinal disorders | 0.6 mg BI 456906 - Actual Maintenance Treatment | 4 | 92 | |
| other | Abdominal distension | Gastrointestinal disorders | 2.4 mg BI 456906 - Actual Maintenance Treatment | 4 | 92 | |
| other | Abdominal distension | Gastrointestinal disorders | 3.6 mg BI 456906 - Actual Maintenance Treatment | 7 | 71 | |
| other | Abdominal distension | Gastrointestinal disorders | 4.8 mg BI 456906 - Actual Maintenance Treatment | 3 | 54 | |
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 3 | 77 | |
| other | Abdominal pain | Gastrointestinal disorders | 0.6 mg BI 456906 - Actual Maintenance Treatment | 4 | 92 | |
| other | Abdominal pain | Gastrointestinal disorders | 2.4 mg BI 456906 - Actual Maintenance Treatment | 10 | 92 | |
| other | Abdominal pain | Gastrointestinal disorders | 3.6 mg BI 456906 - Actual Maintenance Treatment | 5 | 71 | |
| other | Abdominal pain | Gastrointestinal disorders | 4.8 mg BI 456906 - Actual Maintenance Treatment | 3 | 54 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 1 | 77 |
1 to 10 of 230Source ClinicalTrials.gov
See all 230 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 0.6 mg BI 456906 - Actual Maintenance Treatment | 0 | 92 |
| Total, all-cause mortality | 2.4 mg BI 456906 - Actual Maintenance Treatment | 0 | 92 |
| Total, all-cause mortality | 3.6 mg BI 456906 - Actual Maintenance Treatment | 0 | 71 |
| Total, all-cause mortality | 4.8 mg BI 456906 - Actual Maintenance Treatment | 0 | 54 |
| Total, all-cause mortality | Placebo | 0 | 77 |
| Total, other adverse events | 0.6 mg BI 456906 - Actual Maintenance Treatment | 70 | 92 |
| Total, other adverse events | 2.4 mg BI 456906 - Actual Maintenance Treatment | 79 | 92 |
| Total, other adverse events | 3.6 mg BI 456906 - Actual Maintenance Treatment | 64 | 71 |
| Total, other adverse events | 4.8 mg BI 456906 - Actual Maintenance Treatment | 46 | 54 |
| Total, other adverse events | Placebo | 48 | 77 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04667377
GET https://conductscience.org/api/trials/v1/NCT04667377/results?page=2