DRUG
BI 456906
Solution for Injection
A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes.
Status
Completed
Phase
Phase 2
Enrollment
413
Locations
80
Results
Posted
Publications
2
Study summary
What the protocol is testing.
This study is open to adults with type 2 diabetes who take metformin but still have too high blood sugar. The purpose of the study is to find the best dose of BI 456906 that reduces blood sugar. The study also looks at whether BI 456906 helps the participants lose weight. Participants are in the study for about 23 weeks. During this time, most participants visit the study site about 13 times. Some participants visit the study site about 20 times. At the start of the study, the participants are put into 7 groups. The participants in groups 1 to 6 get injections under the skin once or twice every week. Some participants get different doses of BI 456906 and other participants get placebo. Placebo injections look like the BI 456906 injections, but contain no medicine. Participants in group 7 get semaglutide injections every week. Semaglutide is another medicine for adults with type 2 diabetes. During the study, the doctors regularly take blood samples from the participants and measure their body weight. The changes in blood sugar levels and body weight are compared between the groups. The doctors also check the general health of the participants.
Interventions
Treatment arms and agents.
DRUG
Placebo
Solution for Injection
DRUG
Semaglutide
Solution for Injection
Timeline
From registration to results.
First posted
Nov 6, 2019
Study start
Apr 30, 2020
Primary completion
Oct 8, 2021
Study completion
Nov 4, 2021
Results posted
Nov 29, 2022
Registry updated
Nov 29, 2022
Outcomes
What the study measures.
Primary outcomes
Absolute Change in HbA1c From Baseline to 16 Weeks
Time frame · At baseline and at Week 17 (16 weeks after treatment start).
Absolute change in glycosylated hemoglobin A1c (HbA1c) from baseline to 16 weeks after treatment start is presented. The measurements for this outcome were performed at baseline and at Week 17. Absolute change from baseline in HbA1c to 16 weeks after treatment start was calculated by subtracting the baseline HbA1c value from the HbA1c value at Week 17.
Secondary outcomes
Key Secondary Endpoint: The Relative Change in Body Weight From Baseline to 16 Weeks
Time frame · At baseline and at Week 17 (16 weeks after treatment start ).
The relative change in body weight from baseline to 16 weeks after treatment start is presented. The measurements for this outcome were performed at baseline and at Week 17. The relative change in body weight from baseline to 16 weeks after treatment start was calculated as (body weight at Week 17 - body weight at baseline/body weight at baseline) \* 100.
The Absolute Change in Body Weight From Baseline to 16 Weeks
Time frame · At baseline and at Week 17 (16 weeks after treatment start).
The absolute change in body weight from baseline to 16 weeks after treatment start is presented. Measurements for this outcome were performed at baseline and at Week 17. The absolute change in body weight from baseline to 16 weeks after treatment start was calculated as: body weight at Week 17- body weight at baseline.
The Absolute Change in Waist Circumference From Baseline to 16 Weeks
Time frame · At baseline and at Week 17 (16 weeks after treatment start).
The absolute change in waist circumference from baseline to 16 weeks after treatment start is presented. Measurements for this outcome were performed at baseline and at Week 17. The absolute change in waist circumference from baseline to 16 weeks after treatment start was calculated as: waist circumference at Week 17- waist circumference at baseline.
Percentage of Patients With 5 % or Greater Body Weight Loss From Baseline to 16 Weeks
Time frame · At baseline and at Week 17 (16 weeks after treatment start).
The percentage of patients with 5 percent (%) or greater body weight loss from baseline to 16 weeks after treatment start is presented. Measurements for this outcome were performed at baseline and at Week 17.
Percentage of Patients With 10% or Greater Body Weight Loss From Baseline to 16 Weeks
Time frame · At baseline and at Week 17 (16 weeks after treatment start).
The percentage of patients with 10 % or greater body weight loss from baseline to 16 weeks after treatment start is presented. Measurements for this outcome were performed at baseline and at Week 17.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion criteria: * Signed and dated written informed consent in accordance with International conference on harmonization - Good clinical practice (ICH GCP) and local legislation. * Male and female patients 18 years to 75 years (both inclusive) of age on the day of signing informed consent. * Diagnosis of Type 2 diabetes mellitus (T2DM) at least 6 months prior to informed consent. * Glycosylated hemoglobin A1c (HbA1c) 7.0%-10.0% (both inclusive) at screening. * Treatment with a stable dose of metformin ≥ 1000mg/day for at least 3 months prior to screening. * Body mass index (BMI) 25 kg/m2-50 kg/m2 (both inclusive) at screening. * Women of childbearing potential must be ready and able to use highly effective methods of birth control. Exclusion criteria: * Patients with type 1 diabetes. * Exposure to semaglutide, or other Glucagon-like-peptide 1 receptor (GLP-1R) agonists (including combination products) within 3 months prior to screening, or any previous exposure to BI 456906. * Any additional oral anti-hyperglycemic medication beyond metformin within 3 months prior to screening. * Use of insulin for glycemic control within 12 months prior to screening. * Resting Heart Rate \>100 bpm or blood pressure ≥160/95 mmHg at screening. * A marked baseline prolongation of QT/QTc (Fridericia) interval or any other clinically significant Electrocardiogram (ECG) finding at screening. * Body weight change of +/- 5% or more in the past 3 months or on anti-obesity therapies at any time during the 6 months prior to screening. * Continuous oral pharmacotherapy to treat any clinical condition during the Trial. Following medications are allowed: * metformin, anti-hypertensives (any medication known to cause heart block or bradycardia such as beta-blockers, verapamil and diltiazem are excluded unless used to treat heart rate control or hypertension), * Hormone replacement therapy including thyroid hormone, lipid lowering, proton pump inhibitors, H2 blockers for Gastric esophageal reflux disease (GERD), analgesics, * sleep medications * antihistamines * selective Alpha receptor blocker for benign prostatic hyperplasia Patients must be on a stable dose for at least 3 months Prior to Screening * Any suicidal behavior in the past 2 years, any suicidal ideation of type 4 or 5 in the Columbia-suicide severity rating scale (C-SSRS) in the past 3 months at screening. * Chronic or relevant acute infections. * Women who are pregnant, nursing, or who plan to become pregnant while in the trial. * Further exclusion criteria apply.
Study locations
80 registered sites.
Australia · Austria · Canada · Czechia · Germany · Hungary · New Zealand · Poland · Puerto Rico · South Korea · Spain · Taiwan · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
National Research Institute
Huntington Park, California, United States
National Research Institute
Los Angeles, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Indago Research and Health Center
Hialeah, Florida, United States
Meridien Research
Lakeland, Florida, United States
San Marcus Research Clinic, Inc.
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Sensible Healthcare, LLC
Ocoee, Florida, United States
Meridien Research
St. Petersburg, Florida, United States
In-Quest Medical Research, LLC
Suwanee, Georgia, United States
Solaris Clinical Research
Meridian, Idaho, United States
DuPage Medical Group, Ltd
Lombard, Illinois, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
ActivMed Practices & Research
Methuen, Massachusetts, United States
StudyMetrix Research, LLC
City of Saint Peters, Missouri, United States
Mercury Street Medical
Butte, Montana, United States
Palm Research Center
Las Vegas, Nevada, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
PMG Research of Hickory, LLC
Hickory, North Carolina, United States
Lucas Research, Inc.
Morehead City, North Carolina, United States
PMG Research of Raleigh, LLC
Raleigh, North Carolina, United States
PMG Research of Piedmont Healthcare
Statesville, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, United States
Publications
Results and literature.
PMID 42331726 ↗Ekinci EI, Maldonado SG, Unseld A, Martinez JA, Hennige AM, Schoelch C. Dual Glucagon and GLP-1 Receptor Agonist Survodutide Improves Biomarkers of Beta-Cell Function and Insulin Sensitivity in People With Type 2 Diabetes or Living With Overweight/Obesity. Diabetes Obes Metab. 2026 Jun 22. doi: 10.1111/dom.70861. Online ahead of print.PMID 38095657 ↗Bluher M, Rosenstock J, Hoefler J, Manuel R, Hennige AM. Dose-response effects on HbA1c and bodyweight reduction of survodutide, a dual glucagon/GLP-1 receptor agonist, compared with placebo and open-label semaglutide in people with type 2 diabetes: a randomised clinical trial. Diabetologia. 2024 Mar;67(3):470-482. doi: 10.1007/s00125-023-06053-9. Epub 2023 Dec 14.
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More studies on Survodutide.
NCT IDStudyPhase / statusEnrollmentUpdated
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A Study in People With Obesity to Test the Effects of BI 456906 Compared With Semaglutide on Glucagon Receptor Activity in the Liver
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LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
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LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis
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A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight
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A Study in Healthy People or Otherwise Healthy With Overweight or Obesity to Compare 2 Formulations of Survodutide Given in Different Ways, Either as a Pre-filled Syringe or a Pen-like Injector
Boehringer Ingelheim · Healthy · Obesity
Phase 1
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2026-06
A Study to Test Whether Survodutide Improves How the Body Uses Energy and Breaks Down Fat in People With Obesity
Boehringer Ingelheim · Obesity
Phase 1
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