A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Very low dose group
|
Drug: BI 456906
BI 456906
|
Placebo Comparator: Placebo group
|
Drug: Placebo
Placebo
|
Experimental: Low dose group
|
Drug: BI 456906
BI 456906
|
Experimental: Medium dose group
|
Drug: BI 456906
BI 456906
|
Experimental: High dose group
|
Drug: BI 456906
BI 456906
|
Outcome Measures
Primary Outcome Measures
- Percentage change in body weight [From baseline to week 46]
Secondary Outcome Measures
- Weight loss of ≥ 5 percent (%) of baseline weight [At week 46]
- Weight loss of ≥ 10 percent (%) of baseline weight [At week 46]
- Weight loss of ≥ 15 percent (%) of baseline weight [At week 46]
- Absolute change in body weight (kg) [From baseline to week 46]
- Absolute change in waist circumference (cm) [From baseline to week 46]
- Absolute change in systolic blood pressure (mmHg) [From baseline to week 46]
- Absolute change in diastolic blood pressure (mmHg) [From baseline to week 46]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adult ≥ 18 years and < 75 years of age at screening
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Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
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Obesity or Overweight defined as BMI ≥27 kg/m2 at screening
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A minimum absolute body weight of 70 kg for females and 80 kg for males at screening
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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.
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Patients must have undergone at least one previous unsuccessful nonsurgical weight-loss attempt per investigator's judgement
Exclusion criteria:
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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.
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Obesity induced by an endocrinologic disorder (i.e. Cushing Syndrome, hypogonadism, growh hormone deficiency. However, well controlled hypothyroidism, polycystic ovarian disease are still allowed)
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A HbA1c ≥ 6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus
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Exposure to Glucagon like peptide-1 receptor agonist (GLP-1Ra) based therapies within three months prior to screening
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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
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History of major depressive disorder within 2 years before randomization
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Major depressive symptoms (defined as a screening Patient Health Questionnaire-9 [PHQ-9] score ≥15) at screening and/or during screening period
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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
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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.
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Further exclusion criteria apply
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Diablo Clinical Research | Walnut Creek | California | United States | 94598 |
2 | L-MARC Research Center | Louisville | Kentucky | United States | 40213 |
3 | Lucas Research, Inc. | Morehead City | North Carolina | United States | 28557 |
4 | PMG Research of Wilmington, LLC | Wilmington | North Carolina | United States | 28401 |
5 | Valley Weight Loss Clinic | Fargo | North Dakota | United States | 58104 |
6 | Velocity Clinical Research, Inc. | Cleveland | Ohio | United States | 44122 |
7 | TLM Medical Services, LLC | Columbia | South Carolina | United States | 29204 |
8 | Coastal Carolina Research Center | North Charleston | South Carolina | United States | 29405 |
9 | Washington Center for Weight Management and Research, Inc. | Arlington | Virginia | United States | 22206 |
10 | Allegiance Research Specialists | Wauwatosa | Wisconsin | United States | 53226 |
11 | Boden Institute of Obesity, Nutrition, Exercies and Eating Disorders | Camperdown | New South Wales | Australia | 2006 |
12 | Nepean Hospital | Kingswood | New South Wales | Australia | 2747 |
13 | Royal Adelaide Hospital | Adelaide | South Australia | Australia | 5000 |
14 | Eastern Clinical Research Unit | East Ringwood | Victoria | Australia | 3135 |
15 | Austin Health | Heidelberg | Victoria | Australia | 3081 |
16 | UZ Leuven | Leuven | Belgium | 3000 | |
17 | Joanne F Liutkus Medicine Professional Corporation | Cambridge | Ontario | Canada | N1R 7L6 |
18 | Bluewater Clinical Research | Sarnia | Ontario | Canada | N7T 4X3 |
19 | Canadian Phase Onward Inc. | Toronto | Ontario | Canada | M3J 0K2 |
20 | LMC Clinical Research Inc. (Bayview) | Toronto | Ontario | Canada | M4G 3E8 |
21 | Recherche GCP Research | Montreal | Quebec | Canada | H1M 1B1 |
22 | Beijing Chao-Yang Hospital | Beijing | China | 100020 | |
23 | Beijing Luhe Hospital Capital Medical University | Beijing | China | 101199 | |
24 | The First Hospital of Jilin University | Changchun | China | 130021 | |
25 | Wuhan Union Hospital | Wuhan | China | 430022 | |
26 | Klinische Forschung Berlin GbR | Berlin | Germany | 10787 | |
27 | Universitätsklinikum Carl Gustav Carus Dresden | Dresden | Germany | 01307 | |
28 | Seoul National University Bundang Hospital | Seongnam | Korea, Republic of | 13620 | |
29 | Kyung Hee University Hospital at Gangdong | Seoul | Korea, Republic of | 05278 | |
30 | The Catholic University of Korea, Yeouido St.Mary's Hospital | Seoul | Korea, Republic of | 07345 | |
31 | EB Flevoresearch | Almere | Netherlands | 1311 RL | |
32 | PT & R | Beek | Netherlands | 6191 JW | |
33 | Franciscus Gasthuis | Rotterdam | Netherlands | 3045 PM | |
34 | Albert SchweitzerZiekenhuis | Zwijndrecht | Netherlands | 3331 LZ | |
35 | Optimal Clinical Trials | Auckland | New Zealand | 1010 | |
36 | P3 Research | Newtown Wellington NZ | New Zealand | 6021 | |
37 | Salvia Leston&Madej Gen.Partnership,practice,Katowice | Katowice | Poland | 40772 | |
38 | Metabolic Health Center | Poznan | Poland | 60592 | |
39 | Ladulaas Kliniska Studier | Borås | Sweden | 506 30 | |
40 | Forskningsenheten Carlanderska | Göteborg | Sweden | 40545 | |
41 | Akademiska sjukhuset | Uppsala | Sweden | 751 85 | |
42 | Waterloo Medical Centre | Blackpool | United Kingdom | FY4 3AD | |
43 | Clifton Medical Centre, Rotherham | Rotherham | United Kingdom | S65 1DA |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1404-0036
- 2020-002479-37