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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04667377
Registration number
NCT04667377
Ethics application status
Date submitted
8/12/2020
Date registered
14/12/2020
Date last updated
2/11/2023
Titles & IDs
Public title
A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight
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Scientific title
A Phase II, Randomized, Double Blind, Parallel Group,46 Weeks Dose-finding Study of BI 456906 Administered Once Weekly Subcutaneously Compared With Placebo in Patients With Obesity or Overweight
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Secondary ID [1]
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2020-002479-37
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Secondary ID [2]
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1404-0036
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obesity
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Condition category
Condition code
Diet and Nutrition
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Obesity
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Metabolic and Endocrine
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BI 456906
Treatment: Drugs - Placebo
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 -
Treatment: Drugs: BI 456906
BI 456906
Treatment: Drugs: Placebo
Placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage Change in Body Weight From Baseline to Week 46
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Assessment method [1]
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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".
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Timepoint [1]
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Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.
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Secondary outcome [1]
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Weight Loss of = 5% of Baseline Weight at Week 46
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Assessment method [1]
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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.
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Timepoint [1]
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At baseline and at Week 46.
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Secondary outcome [2]
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Weight Loss of = 10% of Baseline Weight at Week 46
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Assessment method [2]
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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.
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Timepoint [2]
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At baseline and at Week 46.
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Secondary outcome [3]
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Weight Loss of = 15% of Baseline Weight at Week 46
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Assessment method [3]
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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.
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Timepoint [3]
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At baseline and at Week 46.
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Secondary outcome [4]
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Absolute Change in Body Weight From Baseline to Week 46
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.
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Secondary outcome [5]
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Absolute Change in Waist Circumference From Baseline to Week 46
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline, Week 6, 12, 18, 24, 32, 40, and 46.
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Secondary outcome [6]
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Absolute Change in Systolic Blood Pressure From Baseline to Week 46
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.
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Secondary outcome [7]
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Absolute Change in Diastolic Blood Pressure From Baseline to Week 46
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/03/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
7/10/2022
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Sample size
Target
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Accrual to date
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Final
387
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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The Boden Initiative - Camperdown
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Recruitment hospital [2]
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Nepean Hospital - Kingswood
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Recruitment hospital [3]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [4]
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Eastern Clinical Research Unit - East Ringwood
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Recruitment hospital [5]
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Austin Health - Heidelberg
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Recruitment postcode(s) [1]
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2006 - Camperdown
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Recruitment postcode(s) [2]
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2747 - Kingswood
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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3135 - East Ringwood
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Recruitment postcode(s) [5]
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3081 - Heidelberg
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Kentucky
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Country [3]
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United States of America
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State/province [3]
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North Carolina
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Country [4]
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United States of America
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State/province [4]
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North Dakota
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Country [5]
0
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United States of America
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State/province [5]
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Ohio
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Country [6]
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United States of America
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State/province [6]
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South Carolina
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Country [7]
0
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United States of America
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State/province [7]
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Virginia
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Country [8]
0
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United States of America
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State/province [8]
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Wisconsin
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Country [9]
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Belgium
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State/province [9]
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Leuven
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Country [10]
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Canada
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State/province [10]
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Ontario
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Country [11]
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Canada
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State/province [11]
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Quebec
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Country [12]
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China
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State/province [12]
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Beijing
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Country [13]
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China
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State/province [13]
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Changchun
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Country [14]
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China
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State/province [14]
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Wuhan
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Country [15]
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Germany
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State/province [15]
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Berlin
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Country [16]
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Germany
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State/province [16]
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Dresden
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Country [17]
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Korea, Republic of
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State/province [17]
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Seongnam
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Country [18]
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Korea, Republic of
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State/province [18]
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Seoul
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Country [19]
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Netherlands
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State/province [19]
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Almere
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Country [20]
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Netherlands
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State/province [20]
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Beek
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Country [21]
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Netherlands
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State/province [21]
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Rotterdam
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Country [22]
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Netherlands
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State/province [22]
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Zwijndrecht
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Country [23]
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New Zealand
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State/province [23]
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Auckland
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Country [24]
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New Zealand
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State/province [24]
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Newtown Wellington NZ
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Country [25]
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Poland
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State/province [25]
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Katowice
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Country [26]
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Poland
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State/province [26]
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Poznan
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Country [27]
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Sweden
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State/province [27]
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Borås
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Country [28]
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Sweden
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State/province [28]
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Göteborg
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Country [29]
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Sweden
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State/province [29]
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Uppsala
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Country [30]
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United Kingdom
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State/province [30]
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Blackpool
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Country [31]
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United Kingdom
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State/province [31]
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Rotherham
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Boehringer Ingelheim
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04667377
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04667377
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