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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Placebo; Drug: BI 456906

• Study Type: Interventional
• Enrollment (Actual): 387
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2006
      • The Boden Initiative
    • Kingswood, New South Wales, Australia, 2747
      • Nepean Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
  • Victoria
    • East Ringwood, Victoria, Australia, 3135
      • Eastern Clinical Research Unit
    • Heidelberg, Victoria, Australia, 3081
      • Austin Health
• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven
• Canada
  • Ontario
    • Cambridge, Ontario, Canada, N3H 4L5
      • Joanne F Liutkus Medicine Professional Corporation
    • Sarnia, Ontario, Canada, N7T 4X3
      • Bluewater Clinical Research
    • Toronto, Ontario, Canada, M4G 3E8
      • LMC Clinical Research Inc. (Bayview)
    • Toronto, Ontario, Canada, M3J 0K2
      • Canadian Phase Onward Inc.
  • Quebec
    • Montreal, Quebec, Canada, H1M 1B1
      • Recherche GCP Research
• China
  • Beijing, China, 100020
    • Beijing Chao-Yang Hospital
  • Beijing, China, 101199
    • Beijing Luhe Hospital Capital Medical University
  • Changchun, China, 130021
    • The First Hospital of Jilin University
  • Wuhan, China, 430022
    • Wuhan Union Hospital
• Germany
  • Berlin, Germany, 10787
    • Klinische Forschung Berlin GbR
  • Dresden, Germany, 01307
    • Universitätsklinikum Carl Gustav Carus Dresden
• Korea, Republic of
  • Seongnam, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 07345
    • The Catholic University of Korea, Yeouido St.Mary's Hospital
  • Seoul, Korea, Republic of, 05278
    • Kyung Hee University Hospital at Gangdong
• Netherlands
  • Almere, Netherlands, 1311 RL
    • EB FlevoResearch
  • Beek, Netherlands, 6191 JW
    • PT & R
  • Rotterdam, Netherlands, 3045 PM
    • Franciscus Gasthuis
  • Zwijndrecht, Netherlands, 3331 LZ
    • Albert SchweitzerZiekenhuis
• New Zealand
  • Auckland, New Zealand, 1010
    • Optimal Clinical Trials
  • Newtown Wellington NZ, New Zealand, 6021
    • P3 Research
• Poland
  • Katowice, Poland, 40772
    • Salvia Lekston I Madej Sp. J.
  • Poznan, Poland, 60592
    • Metabolic Health Center Pawel Bogdanski
• Sweden
  • Borås, Sweden, 506 30
    • Ladulaas Kliniska Studier
  • Göteborg, Sweden, 40545
    • Forskningsenheten Carlanderska
  • Uppsala, Sweden, 751 85
    • Akademiska Sjukhuset
• United Kingdom
  • Blackpool, United Kingdom, FY4 3AD
    • Waterloo Medical Centre
  • Rotherham, United Kingdom, S65 1DA
    • Clifton Medical Centre, Rotherham
• United States
  • California
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • L-MARC Research Center
  • North Carolina
    • Morehead City, North Carolina, United States, 28557
      • Lucas Research, Inc.
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington, LLC
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Valley Weight Loss Clinic
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • Velocity Clinical Research, Inc.
  • South Carolina
    • Columbia, South Carolina, United States, 29204
      • TLM Medical Services, LLC
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center
  • Virginia
    • Arlington, Virginia, United States, 22206
      • Washington Center for Weight Management and Research, Inc.
  • Wisconsin
    • Wauwatosa, Wisconsin, United States, 53226
      • Allegiance Research Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group	Drug: Placebo; Placebo
Experimental: 0.6 mg BI 456906	Drug: BI 456906; BI 456906; Other Names: Survodutide
Experimental: 2.4 mg BI456906	Drug: BI 456906; BI 456906; Other Names: Survodutide
Experimental: 3.6 mg BI 456906	Drug: BI 456906; BI 456906; Other Names: Survodutide
Experimental: 4.8 mg BI 456906	Drug: BI 456906; BI 456906; Other Names: Survodutide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change in Body Weight From Baseline to Week 46	Percentage change in body weight from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit (Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46) as repeated measures, an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. For analysis, all available post-baseline body weight measurements (on- and off-treatment) were used, except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used. That is, a hypothetical strategy was used for intercurrent event (ICE) "COVID-19 pandemic-related early treatment discontinuation", a treatment policy strategy for ICE "non-pandemic-related early treatment discontinuation".	Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Loss of ≥ 5% of Baseline Weight at Week 46	Weight loss of greater than or equal to 5 percent (≥5%) of baseline weight at Week 46 (yes/no), reported as percentage of participants who achieved a weight loss of ≥5% of baseline weight at Week 46. For analysis, all available post-baseline body weight measurements (on- and off-treatment) were used, except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used. Percentages were rounded to one decimal place.	At baseline and at Week 46.
Weight Loss of ≥ 10% of Baseline Weight at Week 46	Weight loss of greater than or equal to 10 percent (≥10%) of baseline weight at Week 46 (yes/no), reported as percentage of participants who achieved a weight loss of ≥10% of baseline weight at Week 46. For analysis, all available post-baseline body weight measurements (on- and off-treatment) were used, except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used. Percentages were rounded to one decimal place.	At baseline and at Week 46.
Weight Loss of ≥ 15% of Baseline Weight at Week 46	Weight loss of greater than or equal to 15 percent (≥15%) of baseline weight at Week 46 (yes/no), reported as percentage of participants who achieved a weight loss of ≥15% of baseline weight at Week 46. For analysis, all available post-baseline body weight measurements (on- and off-treatment) were used, except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used. Percentages were rounded to one decimal place.	At baseline and at Week 46.
Absolute Change in Body Weight From Baseline to Week 46	Absolute change in body weight from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit (Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46) as repeated measures and an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. MMRM analysis was performed on the FAS, using planned maintenance treatment (dose assigned at randomisation) and including only on-treatment data, regardless of whether early treatment discontinuation was COVID-19 related.	Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.
Absolute Change in Waist Circumference From Baseline to Week 46	Absolute change in waist circumference from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline waist circumference as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit (Week 6, 12, 18, 24, 32, 40, and 46) as repeated measures and an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. MMRM analysis was performed on the FAS, using planned maintenance treatment (dose assigned at randomisation) and including only on-treatment data, regardless of whether early treatment discontinuation was COVID-19 related.	Baseline, Week 6, 12, 18, 24, 32, 40, and 46.
Absolute Change in Systolic Blood Pressure From Baseline to Week 46	Absolute change in systolic blood pressure from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline systolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46) as repeated measures and an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. MMRM analysis was performed on the FAS, using planned maintenance treatment (dose assigned at randomisation) and including only on-treatment data, regardless of whether early treatment discontinuation was COVID-19 related.	Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.
Absolute Change in Diastolic Blood Pressure From Baseline to Week 46	Absolute change in diastolic blood pressure from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline diastolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46) as repeated measures and an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. MMRM analysis was performed on the FAS, using planned maintenance treatment (dose assigned at randomisation) and including only on-treatment data, regardless of whether early treatment discontinuation was COVID-19 related.	Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2021
• Primary Completion (Actual): September 15, 2022
• Study Completion (Actual): October 7, 2022

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 8, 2020
• First Posted (Actual): December 14, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: 1404-0036; 2020-002479-37 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No