Oral VK2735 for Weight Management in Adults With Type 2 Diabetes Mellitus Phase 3 (SUNRISE 2)

What Was Tested

This registered phase 3 trial tested VK2735.

This study is one of two planned Phase 3 studies to support the weight management indication for VK2735 Oral in obese (BMI ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2) adults with Type 2 Diabetes Mellitus.

It had four arms (groups): Placebo Assignment (placebo comparator), one (experimental), one (experimental) and one (experimental).

Placebo comparator orally once daily.

The registry classes the interventions as drug.

Who Took Part

The registry lists 560 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: Age ≥18 years of age at the time of signing the informed consent. Body mass index (BMI) ≥ 27 kg/m2.

The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: have type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except type 2 diabetes mellitus (t2dm); have had 1 or more episodes of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 6 months of screening; personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men2).

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The participants were allocated by chance, so the VK2735 group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

Those kept unaware of assignments: participant and investigator.

It started in 2026-11 with completion listed for 2028-10.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percent change in body weight for participants with type 2 diabetes mellitus receiving VK2735 orally once daily (time frame: 68 weeks).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of VK2735 in 560 people.

With 560 participants it is a large trial for this field.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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