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

What Was Tested

This registered phase 3 trial tested Survodutide.

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.

It had nine arms (groups): Part A: Placebo (placebo comparator), one (experimental), one (experimental), Part B: Placebo (placebo comparator) and one (experimental).

Placebo as an add-on to diet and exercise.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 600 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is \>18 years. Body mass index (BMI) ≥23 kg/m2 at screening (Visit 1). Signed and dated written informed consent in accordance with international council for harmonisation - good clinical practice (ICH-GCP) and local legislation prior to admission to the trial.

The full record lists 9 inclusion and 9 exclusion criteria; among the exclusions: type 1 diabetes mellitus (t1d) or latent autoimmune diabetes in adults (lada); history of ketoacidosis or hyperosmolar state or coma within the last 6 months before screening (visit 1) up to and including randomisation (visit 2); hypoglycaemia unawareness or a history of severe hypoglycaemia within the last 3 months before screening (visit 1) up to and including randomisation (visit 2).

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Survodutide group and the comparison group should start out alike.

The Survodutide group and the comparison group ran side by side rather than switching.

As a double-blind Survodutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-08-24 with completion listed for 2028-01-17.

It ran at 120 sites in United States (88), India (13), Canada (10), Australia (4), New Zealand (4) and Puerto Rico (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Absolute change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline to Week 41 (time frame: At baseline and Week 41).

It also tracked 11 secondary outcomes, for example Key secondary endpoint: Absolute change in HbA1c (%) from baseline to Week 53, Absolute change in fasting plasma glucose (mg/dL) from baseline to Week 53, Percent change in body weight (kg) from baseline to Week 53, Relative change in non-HDL (high-density lipoprotein) cholesterol from baseline to Week 53, Relative change in triglycerides from baseline to Week 53 and Estimated glomerular filtration rate (CKD-EPIcr) slope of change from baseline to Week 53.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Survodutide in 600 people.

With 600 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Survodutide compound page, all human trials.