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

NCT04667377 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 1404-00362020-002479-37
• Study Type: interventional
• Target: 387
• Locations: 12 countries
• Sites: 43

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Weight Loss of ≥ 5% of Baseline Weight at Week 46

  At baseline and at Week 46.

• Weight Loss of ≥ 10% of Baseline Weight at Week 46

  At baseline and at Week 46.

• Weight Loss of ≥ 15% of Baseline Weight at Week 46

  At baseline and at Week 46.

• Absolute Change in Body Weight From Baseline to Week 46

  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

  Baseline, Week 6, 12, 18, 24, 32, 40, and 46.

Study Arms (5)

0.6 mg BI 456906

EXPERIMENTAL

Drug: BI 456906

Placebo group

PLACEBO COMPARATOR

Drug: Placebo

2.4 mg BI456906

EXPERIMENTAL

Drug: BI 456906

3.6 mg BI 456906

EXPERIMENTAL

Drug: BI 456906

4.8 mg BI 456906

EXPERIMENTAL

Drug: BI 456906

Interventions

BI 456906 DRUG

BI 456906

Also known as: Survodutide

0.6 mg BI 456906; 2.4 mg BI456906; 3.6 mg BI 456906; 4.8 mg BI 456906

Placebo DRUG

Placebo

Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (43)

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

L-MARC Research Center

Louisville, Kentucky, 40213, United States

Location

Lucas Research, Inc.

Morehead City, North Carolina, 28557, United States

Location

PMG Research of Wilmington, LLC

Wilmington, North Carolina, 28401, United States

Location

Valley Weight Loss Clinic

Fargo, North Dakota, 58104, United States

Location

Velocity Clinical Research, Inc.

Cleveland, Ohio, 44122, United States

Location

TLM Medical Services, LLC

Columbia, South Carolina, 29204, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

Washington Center for Weight Management and Research, Inc.

Arlington, Virginia, 22206, United States

Location

Allegiance Research Specialists

Wauwatosa, Wisconsin, 53226, United States

Location

The Boden Initiative

Camperdown, New South Wales, 2006, Australia

Location

Nepean Hospital

Kingswood, New South Wales, 2747, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Eastern Clinical Research Unit

East Ringwood, Victoria, 3135, Australia

Location

Austin Health

Heidelberg, Victoria, 3081, Australia

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Joanne F Liutkus Medicine Professional Corporation

Cambridge, Ontario, N3H 4L5, Canada

Location

Bluewater Clinical Research

Sarnia, Ontario, N7T 4X3, Canada

Location

Canadian Phase Onward Inc.

Toronto, Ontario, M3J 0K2, Canada

Location

LMC Clinical Research Inc. (Bayview)

Toronto, Ontario, M4G 3E8, Canada

Location

Recherche GCP Research

Montreal, Quebec, H1M 1B1, Canada

Location

Beijing Chao-Yang Hospital

Beijing, 100020, China

Location

Beijing Luhe Hospital Capital Medical University

Beijing, 101199, China

Location

The First Hospital of Jilin University

Changchun, 130021, China

Location

Wuhan Union Hospital

Wuhan, 430022, China

Location

Klinische Forschung Berlin GbR

Berlin, 10787, Germany

Location

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

Location

EB Flevoresearch

Almere Stad, 1311 RL, Netherlands

Location

PT & R

Beek, 6191 JW, Netherlands

Location

Franciscus Gasthuis

Rotterdam, 3045 PM, Netherlands

Location

Albert SchweitzerZiekenhuis

Zwijndrecht, 3331 LZ, Netherlands

Location

Optimal Clinical Trials

Auckland, 1010, New Zealand

Location

P3 Research

Newtown Wellington NZ, 6021, New Zealand

Location

Salvia Lekston I Madej Sp. J.

Katowice, 40772, Poland

Location

Metabolic Health Center Pawel Bogdanski

Poznan, 60592, Poland

Location

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, 05278, South Korea

Location

The Catholic University of Korea, Yeouido St.Mary's Hospital

Seoul, 07345, South Korea

Location

Ladulaas Kliniska Studier

Borås, 506 30, Sweden

Location

Forskningsenheten Carlanderska

Gothenburg, 40545, Sweden

Location

Akademiska sjukhuset

Uppsala, 751 85, Sweden

Location

Waterloo Medical Centre

Blackpool, FY4 3AD, United Kingdom

Location

Clifton Medical Centre, Rotherham

Rotherham, S65 1DA, United Kingdom

Location

Related Publications (2)

• le Roux CW, Steen O, Lucas KJ, Startseva E, Unseld A, Hussain SA, Hennige AM. Subgroup analysis by sex and baseline BMI in people with a BMI >/=27 kg/m2 in the phase 2 trial of survodutide, a glucagon/GLP-1 receptor dual agonist. Diabetes Obes Metab. 2025 Apr;27(4):1773-1782. doi: 10.1111/dom.16167. Epub 2025 Jan 16.

  PMID: 39821928 DERIVED

• le Roux CW, Steen O, Lucas KJ, Startseva E, Unseld A, Hennige AM. Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial. Lancet Diabetes Endocrinol. 2024 Mar;12(3):162-173. doi: 10.1016/S2213-8587(23)00356-X. Epub 2024 Feb 5.

  PMID: 38330987 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Obesity

Interventions

BI 456906

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Boehringer Ingelheim, Call Centre
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 14, 2020
• Study Start: March 8, 2021
• Primary Completion: September 15, 2022
• Study Completion: October 7, 2022
• Last Updated: November 2, 2023
• Results First Posted: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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'.

Locations

GB (2); BE (1); AU (5); NZ (2); PL (2); SE (3); CN (4); CA (5); KR (3); NL (4); US (10); DE (2)