Back to resultsA Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight
Primary Purpose
Obesity
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BI 456906
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
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
Sites / Locations
- Diablo Clinical Research
- L-MARC Research Center
- Lucas Research, Inc.
- PMG Research of Wilmington, LLC
- Valley Weight Loss Clinic
- Velocity Clinical Research, Inc.
- TLM Medical Services, LLC
- Coastal Carolina Research Center
- Washington Center for Weight Management and Research, Inc.
- Allegiance Research Specialists
- The Boden Initiative
- Nepean Hospital
- Royal Adelaide Hospital
- Eastern Clinical Research Unit
- Austin Health
- UZ Leuven
- Joanne F Liutkus Medicine Professional Corporation
- Bluewater Clinical Research
- Canadian Phase Onward Inc.
- LMC Clinical Research Inc. (Bayview)
- Recherche GCP Research
- Beijing Chao-Yang Hospital
- Beijing Luhe Hospital Capital Medical University
- The First Hospital of Jilin University
- Wuhan Union Hospital
- Klinische Forschung Berlin GbR
- Universitätsklinikum Carl Gustav Carus Dresden
- Seoul National University Bundang Hospital
- Kyung Hee University Hospital at Gangdong
- The Catholic University of Korea, Yeouido St.Mary's Hospital
- EB Flevoresearch
- PT & R
- Franciscus Gasthuis
- Albert SchweitzerZiekenhuis
- Optimal Clinical Trials
- P3 Research
- Salvia Leston&Madej Gen.Partnership,practice,Katowice
- Metabolic Health Center Pawel Bogdanski
- Ladulaas Kliniska Studier
- Forskningsenheten Carlanderska
- Akademiska sjukhuset
- Waterloo Medical Centre
- Clifton Medical Centre, Rotherham
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
0.6 mg BI 456906
Placebo group
2.4 mg BI456906
3.6 mg BI 456906
4.8 mg BI 456906
Arm Description
Outcomes
Primary Outcome Measures
Percentage change in body weight
Secondary Outcome Measures
Weight loss of ≥ 5 percent (%) of baseline weight
Weight loss of ≥ 10 percent (%) of baseline weight
Weight loss of ≥ 15 percent (%) of baseline weight
Absolute change in body weight (kg)
Absolute change in waist circumference (cm)
Absolute change in systolic blood pressure (mmHg)
Absolute change in diastolic blood pressure (mmHg)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04667377
Brief Title
A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
September 15, 2022 (Actual)
Study Completion Date
October 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
387 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.6 mg BI 456906
Arm Type
Experimental
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Title
2.4 mg BI456906
Arm Type
Experimental
Arm Title
3.6 mg BI 456906
Arm Type
Experimental
Arm Title
4.8 mg BI 456906
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BI 456906
Intervention Description
BI 456906
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Percentage change in body weight
Time Frame
From baseline to week 46
Secondary Outcome Measure Information:
Title
Weight loss of ≥ 5 percent (%) of baseline weight
Time Frame
At week 46
Title
Weight loss of ≥ 10 percent (%) of baseline weight
Time Frame
At week 46
Title
Weight loss of ≥ 15 percent (%) of baseline weight
Time Frame
At week 46
Title
Absolute change in body weight (kg)
Time Frame
From baseline to week 46
Title
Absolute change in waist circumference (cm)
Time Frame
From baseline to week 46
Title
Absolute change in systolic blood pressure (mmHg)
Time Frame
From baseline to week 46
Title
Absolute change in diastolic blood pressure (mmHg)
Time Frame
From baseline to week 46
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Diablo Clinical Research
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
L-MARC Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Lucas Research, Inc.
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
PMG Research of Wilmington, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Valley Weight Loss Clinic
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Velocity Clinical Research, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
TLM Medical Services, LLC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Coastal Carolina Research Center
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
Washington Center for Weight Management and Research, Inc.
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22206
Country
United States
Facility Name
Allegiance Research Specialists
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
The Boden Initiative
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2006
Country
Australia
Facility Name
Nepean Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Eastern Clinical Research Unit
City
East Ringwood
State/Province
Victoria
ZIP/Postal Code
3135
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Joanne F Liutkus Medicine Professional Corporation
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N3H 4L5
Country
Canada
Facility Name
Bluewater Clinical Research
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Canadian Phase Onward Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3J 0K2
Country
Canada
Facility Name
LMC Clinical Research Inc. (Bayview)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada
Facility Name
Recherche GCP Research
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1M 1B1
Country
Canada
Facility Name
Beijing Chao-Yang Hospital
City
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Beijing Luhe Hospital Capital Medical University
City
Beijing
ZIP/Postal Code
101199
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
Wuhan Union Hospital
City
Wuhan
ZIP/Postal Code
430022
Country
China
Facility Name
Klinische Forschung Berlin GbR
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital at Gangdong
City
Seoul
ZIP/Postal Code
05278
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Yeouido St.Mary's Hospital
City
Seoul
ZIP/Postal Code
07345
Country
Korea, Republic of
Facility Name
EB Flevoresearch
City
Almere
ZIP/Postal Code
1311 RL
Country
Netherlands
Facility Name
PT & R
City
Beek
ZIP/Postal Code
6191 JW
Country
Netherlands
Facility Name
Franciscus Gasthuis
City
Rotterdam
ZIP/Postal Code
3045 PM
Country
Netherlands
Facility Name
Albert SchweitzerZiekenhuis
City
Zwijndrecht
ZIP/Postal Code
3331 LZ
Country
Netherlands
Facility Name
Optimal Clinical Trials
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
P3 Research
City
Newtown Wellington NZ
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Salvia Leston&Madej Gen.Partnership,practice,Katowice
City
Katowice
ZIP/Postal Code
40772
Country
Poland
Facility Name
Metabolic Health Center Pawel Bogdanski
City
Poznan
ZIP/Postal Code
60592
Country
Poland
Facility Name
Ladulaas Kliniska Studier
City
Borås
ZIP/Postal Code
506 30
Country
Sweden
Facility Name
Forskningsenheten Carlanderska
City
Göteborg
ZIP/Postal Code
40545
Country
Sweden
Facility Name
Akademiska sjukhuset
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Waterloo Medical Centre
City
Blackpool
ZIP/Postal Code
FY4 3AD
Country
United Kingdom
Facility Name
Clifton Medical Centre, Rotherham
City
Rotherham
ZIP/Postal Code
S65 1DA
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
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'.
IPD Sharing URL
https://www.mystudywindow.com/msw/datasharing
Links:
URL
https://www.mystudywindow.com/
Description
Related Info
Learn more about this trial
A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight
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