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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04667377
Recruitment Status : Active, not recruiting
First Posted : December 14, 2020
Last Update Posted : August 10, 2022
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE December 8, 2020
First Posted Date  ICMJE December 14, 2020
Last Update Posted Date August 10, 2022
Actual Study Start Date  ICMJE March 8, 2021
Estimated Primary Completion Date September 29, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2020)
Percentage change in body weight [ Time Frame: From baseline to week 46 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2020)
  • Weight loss of ≥ 5 percent (%) of baseline weight [ Time Frame: At week 46 ]
  • Weight loss of ≥ 10 percent (%) of baseline weight [ Time Frame: At week 46 ]
  • Weight loss of ≥ 15 percent (%) of baseline weight [ Time Frame: At week 46 ]
  • Absolute change in body weight (kg) [ Time Frame: From baseline to week 46 ]
  • Absolute change in waist circumference (cm) [ Time Frame: From baseline to week 46 ]
  • Absolute change in systolic blood pressure (mmHg) [ Time Frame: From baseline to week 46 ]
  • Absolute change in diastolic blood pressure (mmHg) [ Time Frame: From baseline to week 46 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2020)
  • Weight loss of ≥ 5% of baseline weight [ Time Frame: At week 46 ]
  • Weight loss of ≥ 10% of baseline weight [ Time Frame: At week 46 ]
  • Weight loss of ≥ 15% of baseline weight [ Time Frame: At week 46 ]
  • Absolute change in body weight (kg) [ Time Frame: From baseline to week 46 ]
  • Absolute change in waist circumference (cm) [ Time Frame: From baseline to week 46 ]
  • Absolute change in systolic blood pressure (mmHg) [ Time Frame: From baseline to week 46 ]
  • Absolute change in diastolic blood pressure (mmHg) [ Time Frame: From baseline to week 46 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Drug: BI 456906
    BI 456906
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Very low dose group
    Intervention: Drug: BI 456906
  • Placebo Comparator: Placebo group
    Intervention: Drug: Placebo
  • Experimental: Low dose group
    Intervention: Drug: BI 456906
  • Experimental: Medium dose group
    Intervention: Drug: BI 456906
  • Experimental: High dose group
    Intervention: Drug: BI 456906
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 18, 2021)
387
Original Estimated Enrollment  ICMJE
 (submitted: December 8, 2020)
350
Estimated Study Completion Date  ICMJE October 20, 2022
Estimated Primary Completion Date September 29, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   China,   Germany,   Korea, Republic of,   Netherlands,   New Zealand,   Poland,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04667377
Other Study ID Numbers  ICMJE 1404-0036
2020-002479-37 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.

Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
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.
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'.
URL: https://www.mystudywindow.com/msw/datasharing
Current Responsible Party Boehringer Ingelheim
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Boehringer Ingelheim
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP