A Study to Test Whether Survodutide Helps People With Type 2 Diabetes Control Their Blood Sugar

Conditions

• Type 2 Diabetes

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  Placebo
• Survodutide — DRUG
  Survodutide

Study Details

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.

Key Dates

First listed

Aug 10, 2026

Start date

Aug 24, 2026

Status verified

Aug 2026

Primary completion

Jan 17, 2028

Completion

May 1, 2028

Study Design

Enrollment

600 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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 Outcome Measure

Absolute change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline to Week 41 [ Time Frame: At baseline and Week 41. ]

Central Contacts

• Boehringer Ingelheim
  1-800-243-0127
  [email protected]

Locations (89)

Find similar trials in Birmingham, AL

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