VK2735 for Weight Management Phase 2

What Was Tested

The trial (phase 2) is built around VK2735.

VK2735 or matched placebo will be administered once weekly.

It had five arms (groups): VK2735 (Placebo) (placebo comparator), one (experimental), one (experimental), one (experimental) and one (experimental).

Placebo.

VK2735 is a peptide GLP-1 and GIP dual agonist.

VK2735 is a peptide GLP-1 and GIP dual agonist.

The registry classes the interventions as biological.

Who Took Part

176 actual participants took part.

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: Age ≥18 years of age at the time of signing the informed consent. Body mass index (BMI) ≥30 kg/m2 OR ≥27 kg/m2 with at least one weight-related co-morbid condition (treated or untreated), and BMI \<50 kg/m2.

The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: current or past diagnosis of diabetes mellitus (including type 1, type 2, gestational); current or past diagnosis of chronic pancreatitis; calcitonin ≥20 ng/l measured by central laboratory at screening (individuals with elevated calcitonin at initial screening may be re-screened).

How the Study Was Run

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

Because people in this VK2735 study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The VK2735 group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received VK2735.

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

It started in 2023-08-31 with completion listed for 2024-02-27.

It ran at 20 sites in United States (20).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percent (relative) change from baseline to Week 13 in body weight (time frame: 13 weeks).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of VK2735 in 176 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the VK2735 compound page, all human trials.