Trial · Interventional
RecruitingPhase 3Registry dataA Study to Test Whether Survodutide Helps People With Type 2 Diabetes Control Their Blood Sugar
Overview
- Status
- Recruiting
- Phase
- Phase 3
- Enrollment
- 600 participants (estimated)
- Sponsor
- Boehringer Ingelheim · Industry
- Design
- Randomized · Quadruple masking
- Countries
6 countries
United States, Australia, Canada, India, New Zealand, Puerto Rico
- Start
- 24 Aug 2026
- Primary completion
- 17 Jan 2028 (estimated)
- Completion
- 1 May 2028 (estimated)
- First posted
- 10 Aug 2026
- Last update posted
- 30 Sept 2026
- Conditions
- Type 2 Diabetes
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 3
A Study to Test Whether Survodutide Helps People With Type 2 Diabetes Control Their Blood Sugar
NCT0775446124 Aug 2026 to est. 1 May 2028
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study aims to find out whether a study medicine called survodutide helps people control their blood sugar. Adults who live with type 2 diabetes and with a body mass index (BMI) of 23 kg/m2 or higher can join. The study has 3 parts. In each part the study compares survodutide with placebo. Survodutide is being developed to treat several health problems including type 2 diabetes. Placebo looks like survodutide but does not contain any medicine. Depending on a person's diabetes treatment, a person will be assigned either to * Part A: healthy eating and physical activity * Part B: diabetes tablets (no injection of insulin) * Part C: injection of insulin (with or without diabetes tablets) Participants are randomly put into 1 of 3 groups, which means the group is chosen by chance. Two groups of participants get survodutide at different dose levels, and the third group gets placebo as injection under the skin once a week. You have a 2 in 3 chance of getting survodutide. During the study, participants continue their regular diabetes treatment. Participants are in the study for about 1 year and 2 months. During this time, they attend up to 12 visits at the site and receive at least 9 phone calls. Study doctors regularly test participants' blood sugar by checking their HbA1c values and other laboratory test results. The study doctor also regularly checks participants' health and takes note of any changes. For each study part, the results will be compared between the survodutide and the placebo group to see whether the treatment works.
Interventions
- PlaceboDrug
- SurvodutideDrug
Arms9
Placebo comparator
Part A: Placebo
Placebo as an add-on to diet and exercise.
Experimental
Part A: Low-dose survodutide
Low-dose survodutide as an add-on to diet and exercise.
Experimental
Part A: High-dose survodutide
High-dose survodutide as add-on to diet and exercise
Placebo comparator
Part B: Placebo
Placebo as an add-on to anti-diabetic drugs.
Experimental
Part B: Low-dose survodutide
Low-dose survodutide as an add-on to anti-diabetic drugs.
Experimental
Part B: High-dose survodutide
High-dose survodutide as an add-on to anti-diabetic drugs.
Placebo comparator
Part C: Placebo
Placebo as an add-on to basal insulin therapy with or without anti-diabetic drugs.
Experimental
Part C: Low-dose survodutide
Low-dose as an add-on to basal insulin therapy with or without anti-diabetic drugs.
Experimental
Part C: High-dose survodutide
High-dose as an add-on to basal insulin therapy with or without anti-diabetic drugs.
Primary outcomes1
Outcomes the sponsor listed as primary.
Absolute change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline to Week 41
Time frame · At baseline and Week 41.
Secondary outcomes(11)
Key secondary endpoint: Absolute change in HbA1c (%) from baseline to Week 53
Time frame · At baseline and Week 53.
Key secondary endpoint: Achievement of HbA1c <6.5% (yes/no) at Week 41
Time frame · At baseline and Week 41.
Achievement of HbA1c <5.7% (yes/no) at Week 41
Time frame · At Week 41.
Absolute change in fasting plasma glucose (mg/dL) from baseline to Week 53
Time frame · At baseline and Week 53.
Percent change in body weight (kg) from baseline to Week 53
Time frame · At baseline and Week 53.
Relative change in non-HDL (high-density lipoprotein) cholesterol from baseline to Week 53
Time frame · At baseline and Week 53.
Relative change in triglycerides from baseline to Week 53
Time frame · At baseline and Week 53.
Estimated glomerular filtration rate (CKD-EPIcr) slope of change from baseline to Week 53
Time frame · At baseline and Week 53.
Registry description
CKD-EPIcr: Chronic Kidney Disease Epidemiology Collaboration creatinine equation
Relative change in urinary albumin-to-creatinine ratio (UACR) from baseline to Week 53 as a continuous variable
Time frame · At baseline and Week 53.
Absolute change in systolic blood pressure (SBP, mmHg) from baseline to Week 53
Time frame · At baseline and Week 53.
Part C: Absolute change in daily basal insulin dose from baseline to Week 53
Time frame · At baseline and Week 53.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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