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

What Was Tested

In this phase 2 trial, researchers set out to test Survodutide.

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.

It had five arms (groups): one (experimental), Placebo group (placebo comparator), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 387 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: 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. Patients must have undergone at least one previous unsuccessful nonsurgical weight-loss attempt per investigator's judgement.

The full record lists 6 inclusion and 10 exclusion criteria; among the exclusions: obesity induced by an endocrinologic disorder (i.e. cushing syndrome, hypogonadism, growh hormone deficiency. however, well controlled hypothyroidism, polycystic ovarian disease are still allowed); exposure to glucagon like peptide-1 receptor agonist (glp-1ra) based therapies within three months prior to screening; history of major depressive disorder within 2 years before randomization.

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.

Neither the participants nor the staff measuring them knew who was on Survodutide, so expectations could not easily colour the readings.

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

It started in 2021-03-08 with completion listed for 2022-09-15.

It ran at 43 sites in United States (10), Australia (5), Canada (5), China (4), Netherlands (4) and South Korea (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage Change in Body Weight From Baseline to Week 46 (time frame: Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46).

It also tracked 7 secondary outcomes, for example Absolute Change in Body Weight From Baseline to Week 46, Absolute Change in Waist Circumference From Baseline to Week 46, Absolute Change in Systolic Blood Pressure From Baseline to Week 46 and Absolute Change in Diastolic Blood Pressure From Baseline to Week 46.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Survodutide in 387 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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