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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04667377




Registration number
NCT04667377
Ethics application status
Date submitted
8/12/2020
Date registered
14/12/2020

Titles & IDs
Public title
A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight
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
Secondary ID [1] 0 0
2020-002479-37
Secondary ID [2] 0 0
1404-0036
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage Change in Body Weight From Baseline to Week 46
Timepoint [1] 0 0
Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.
Secondary outcome [1] 0 0
Weight Loss of = 5% of Baseline Weight at Week 46
Timepoint [1] 0 0
At baseline and at Week 46.
Secondary outcome [2] 0 0
Weight Loss of = 10% of Baseline Weight at Week 46
Timepoint [2] 0 0
At baseline and at Week 46.
Secondary outcome [3] 0 0
Weight Loss of = 15% of Baseline Weight at Week 46
Timepoint [3] 0 0
At baseline and at Week 46.
Secondary outcome [4] 0 0
Absolute Change in Body Weight From Baseline to Week 46
Timepoint [4] 0 0
Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.
Secondary outcome [5] 0 0
Absolute Change in Waist Circumference From Baseline to Week 46
Timepoint [5] 0 0
Baseline, Week 6, 12, 18, 24, 32, 40, and 46.
Secondary outcome [6] 0 0
Absolute Change in Systolic Blood Pressure From Baseline to Week 46
Timepoint [6] 0 0
Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.
Secondary outcome [7] 0 0
Absolute Change in Diastolic Blood Pressure From Baseline to Week 46
Timepoint [7] 0 0
Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.

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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/10/2022
Sample size
Target
Accrual to date
Final
387
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
The Boden Initiative - Camperdown
Recruitment hospital [2] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Eastern Clinical Research Unit - East Ringwood
Recruitment hospital [5] 0 0
Austin Health - Heidelberg
Recruitment postcode(s) [1] 0 0
2006 - Camperdown
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3135 - East Ringwood
Recruitment postcode(s) [5] 0 0
3081 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Kentucky
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
North Dakota
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
South Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Virginia
Country [8] 0 0
United States of America
State/province [8] 0 0
Wisconsin
Country [9] 0 0
Belgium
State/province [9] 0 0
Leuven
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
China
State/province [12] 0 0
Beijing
Country [13] 0 0
China
State/province [13] 0 0
Changchun
Country [14] 0 0
China
State/province [14] 0 0
Wuhan
Country [15] 0 0
Germany
State/province [15] 0 0
Berlin
Country [16] 0 0
Germany
State/province [16] 0 0
Dresden
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Seongnam
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Seoul
Country [19] 0 0
Netherlands
State/province [19] 0 0
Almere
Country [20] 0 0
Netherlands
State/province [20] 0 0
Beek
Country [21] 0 0
Netherlands
State/province [21] 0 0
Rotterdam
Country [22] 0 0
Netherlands
State/province [22] 0 0
Zwijndrecht
Country [23] 0 0
New Zealand
State/province [23] 0 0
Auckland
Country [24] 0 0
New Zealand
State/province [24] 0 0
Newtown Wellington NZ
Country [25] 0 0
Poland
State/province [25] 0 0
Katowice
Country [26] 0 0
Poland
State/province [26] 0 0
Poznan
Country [27] 0 0
Sweden
State/province [27] 0 0
Borås
Country [28] 0 0
Sweden
State/province [28] 0 0
Göteborg
Country [29] 0 0
Sweden
State/province [29] 0 0
Uppsala
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Blackpool
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Rotherham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Available to whom?
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04667377