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Trial · Interventional

CompletedPhase 2Results postedRegistry data

A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight

NCTNCT04667377 (opens ClinicalTrials.gov in a new tab)Other id1404-0036Other id2020-002479-37
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
387 participants (actual)
Sponsor
Boehringer Ingelheim · Industry
Design
Randomized · Quadruple masking
Countries
12 countries

United States, Australia, Belgium, Canada, China, Germany, Netherlands, New Zealand, Poland, South Korea, Sweden, United Kingdom

Start
8 Mar 2021
Primary completion
15 Sept 2022
Completion
7 Oct 2022
First posted
14 Dec 2020
Last update posted
2 Nov 2023
Conditions
Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202120222023
  1. Ph 2

    A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight

    NCT04667377

    8 Mar 2021 to 7 Oct 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study is open to adults, aged 18 to 75 years, with overweight or obesity. People with body mass index (BMI) of 27 or higher to join the study. People who have diabetes cannot participate. The purpose of this study is to find out whether a medicine called BI 456906 helps people lose weight. Participants are put into 5 groups by chance. 4 groups get different doses of BI 456906. The fifth group gets placebo. Participants get BI 456906 or placebo as injections under the skin once a week. Placebo injections look like BI 456906 injections but do not contain any medicine. Participants are in the study for about a year. During this time, there are about 20 in-person visits to the study site. At the study site visits, doctors measure participants' body weight. Results are compared between the BI 456906 groups and the placebo group. The doctors also regularly check the general health of the participants.

Interventions

  • BI 456906Drug
  • PlaceboDrug

Arms5

  • Experimental

    0.6 mg BI 456906

  • Placebo comparator

    Placebo group

  • Experimental

    2.4 mg BI456906

  • Experimental

    3.6 mg BI 456906

  • Experimental

    4.8 mg BI 456906

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage Change in Body Weight From Baseline to Week 46

    Time frame · Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.

    Registry description

    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 outcomes(7)

  1. Weight Loss of ≥ 5% of Baseline Weight at Week 46

    Time frame · At baseline and at Week 46.

    Registry description

    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.

  2. Weight Loss of ≥ 10% of Baseline Weight at Week 46

    Time frame · At baseline and at Week 46.

    Registry description

    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.

  3. Weight Loss of ≥ 15% of Baseline Weight at Week 46

    Time frame · At baseline and at Week 46.

    Registry description

    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.

  4. Absolute Change in Body Weight From Baseline to Week 46

    Time frame · Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.

    Registry description

    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.

  5. Absolute Change in Waist Circumference From Baseline to Week 46

    Time frame · Baseline, Week 6, 12, 18, 24, 32, 40, and 46.

    Registry description

    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.

  6. Absolute Change in Systolic Blood Pressure From Baseline to Week 46

    Time frame · Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.

    Registry description

    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.

  7. Absolute Change in Diastolic Blood Pressure From Baseline to Week 46

    Time frame · Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· 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

GroupValue (Percentage change)Spread
0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation)-6.191.07
2.4 mg BI 456906 - Planned Maintenance Treatment-12.511.01
3.6 mg BI 456906 - Planned Maintenance Treatment-13.221.04
4.8 mg BI 456906 - Planned Maintenance Treatment-14.941.01
Placebo-2.821.06
Secondary and other outcome results(7)
Secondary outcomeNumber· At baseline and at Week 46.

Weight Loss of ≥ 5% of Baseline Weight at Week 46

GroupValue (Percentage of participants)
0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation)60.7
2.4 mg BI 456906 - Planned Maintenance Treatment81.0
3.6 mg BI 456906 - Planned Maintenance Treatment82.0
4.8 mg BI 456906 - Planned Maintenance Treatment82.8
Placebo25.9
Secondary outcomeNumber· At baseline and at Week 46.

Weight Loss of ≥ 10% of Baseline Weight at Week 46

GroupValue (Percentage of participants)
0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation)33.9
2.4 mg BI 456906 - Planned Maintenance Treatment65.5
3.6 mg BI 456906 - Planned Maintenance Treatment65.6
4.8 mg BI 456906 - Planned Maintenance Treatment68.8
Placebo11.1
Secondary outcomeNumber· At baseline and at Week 46.

Weight Loss of ≥ 15% of Baseline Weight at Week 46

GroupValue (Percentage of particpants)
0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation)12.5
2.4 mg BI 456906 - Planned Maintenance Treatment37.9
3.6 mg BI 456906 - Planned Maintenance Treatment45.9
4.8 mg BI 456906 - Planned Maintenance Treatment54.7
Placebo5.6
Secondary outcomeLeast squares mean· 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

GroupValue (Kilogram (kg))Spread
0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation)-7.211.06
2.4 mg BI 456906 - Planned Maintenance Treatment-14.751.03
3.6 mg BI 456906 - Planned Maintenance Treatment-15.641.04
4.8 mg BI 456906 - Planned Maintenance Treatment-18.471.04
Placebo-2.681.04
Secondary outcomeLeast squares mean· Baseline, Week 6, 12, 18, 24, 32, 40, and 46.

Absolute Change in Waist Circumference From Baseline to Week 46

GroupValue (Centimeter (cm))Spread
0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation)-8.321.22
2.4 mg BI 456906 - Planned Maintenance Treatment-14.991.21
3.6 mg BI 456906 - Planned Maintenance Treatment-14.961.19
4.8 mg BI 456906 - Planned Maintenance Treatment-16.011.19
Placebo-3.961.20
Secondary outcomeLeast squares mean· 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

GroupValue (Millimeter of mercury (mmHg))Spread
0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation)-6.191.47
2.4 mg BI 456906 - Planned Maintenance Treatment-8.081.48
3.6 mg BI 456906 - Planned Maintenance Treatment-8.661.44
4.8 mg BI 456906 - Planned Maintenance Treatment-8.621.46
Placebo-2.461.46
Secondary outcomeLeast squares mean· 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

GroupValue (Millimeter of mercury (mmHg))Spread
0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation)-3.310.90
2.4 mg BI 456906 - Planned Maintenance Treatment-4.360.90
3.6 mg BI 456906 - Planned Maintenance Treatment-4.310.87
4.8 mg BI 456906 - Planned Maintenance Treatment-4.800.89
Placebo-1.870.89

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
0.6 mg BI 456906 - Actual Maintenance TreatmentParticipants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and 2, and 0.6 mg on Week 3 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 0.6 mg BI 456906. Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.0 / 922 / 9270 / 92
2.4 mg BI 456906 - Actual Maintenance TreatmentParticipants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 to Week 10, 1.8 mg on Week 11 to Week 14 and 2.4 mg on Week 15 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 2.4 mg BI 456906. Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.0 / 923 / 9279 / 92
3.6 mg BI 456906 - Actual Maintenance TreatmentParticipants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 to Week 10, 1.8 mg on Week 11 and Week 12, 2.4 mg on Week 13 and Week 14, 3.0 mg on Week 15 and Week 16, and 3.6 mg on Week 17 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 3.6 mg BI 456906. Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.0 / 714 / 7164 / 71
4.8 mg BI 456906 - Actual Maintenance TreatmentParticipants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 and Week 8, 1.8 mg on Week 9 and Week 10, 2.4 mg on Week 11 and Week 12, 3.3 mg on Week 13 and Week 14, 4.2 mg on Week 15 and Week 16, and 4.8 mg on Week 17 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 4.8 mg BI 456906. Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.0 / 544 / 5446 / 54
PlaceboParticipants with obesity or overweight were administered a solution for injection of Placebo, by a weekly subcutaneous injection of two syringes on the same injection day, for 46 weeks.0 / 775 / 7748 / 77

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

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Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Adult ≥ 18 years and \< 75 years of age at screening * Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. * Obesity or Overweight defined as BMI ≥27 kg/m2 at screening * A minimum absolute body weight of 70 kg for females and 80 kg for males at screening * Male or female participants. Women of childbearing potential (WOCBP)1 must be willing and able to use two forms of effective contraception where at least one form is highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information. * Patients must have undergone at least one previous unsuccessful nonsurgical weight-loss attempt per investigator's judgement Exclusion criteria: * Body weight change of over +/- 5% or more in the past 12 weeks prior to randomization. There must be documentation of weight in the past 12 weeks before randomization. * Obesity induced by an endocrinologic disorder (i.e. Cushing Syndrome, hypogonadism, growh hormone deficiency. However, well controlled hypothyroidism, polycystic ovarian disease are still allowed) * A HbA1c ≥ 6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus * Exposure to Glucagon like peptide-1 receptor agonist (GLP-1Ra) based therapies within three months prior to screening * Any suicidal behaviour in the past 2 years, any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (CSSRS) within 3 months before screening, or during screening period * History of major depressive disorder within 2 years before randomization * Major depressive symptoms (defined as a screening Patient Health Questionnaire-9 \[PHQ-9\] score ≥15) at screening and/or during screening period * Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders at screening * Chronic or relevant acute infections (including but not limited to respiratory tract infections, urinary tract infection, bladder infection, enterocolitis, abscess, tuberculosis, meningitis, influenza, Epstein-Barr virus, HIV/AIDS, and hepatitis B or C, and severe acute respiratory syndrome coronavirus type 19 (SARS CoV-2) (as confirmed by Polychain reaction (PCR) test)), within 2 weeks from screening or during screening. * Further exclusion criteria apply

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