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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04667377
Collaborator
(none)
387
43
5
19.4
9
0.5

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
  • Drug: BI 456906
  • Drug: Placebo
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
387 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 8, 2021
Anticipated Primary Completion Date :
Sep 29, 2022
Anticipated Study Completion Date :
Oct 20, 2022

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

  1. Percentage change in body weight [From baseline to week 46]

Secondary Outcome Measures

  1. Weight loss of ≥ 5 percent (%) of baseline weight [At week 46]

  2. Weight loss of ≥ 10 percent (%) of baseline weight [At week 46]

  3. Weight loss of ≥ 15 percent (%) of baseline weight [At week 46]

  4. Absolute change in body weight (kg) [From baseline to week 46]

  5. Absolute change in waist circumference (cm) [From baseline to week 46]

  6. Absolute change in systolic blood pressure (mmHg) [From baseline to week 46]

  7. Absolute change in diastolic blood pressure (mmHg) [From baseline to week 46]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

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.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT04667377
Other Study ID Numbers:
  • 1404-0036
  • 2020-002479-37
First Posted:
Dec 14, 2020
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 10, 2022