Oral VK2735 for Weight Management Phase 3 (SUNRISE 1)

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 ≥ 27kg/m2) adults with at least one weight-related comorbidity without 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

Enrollment: 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) ≥30 kg/m2 OR ≥27 kg/m2 with at least one weight-related co-morbid condition (treated or untreated). Weight-related co-morbid conditions include hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease. Cardiovascular disease includes, for example, ischemic cardiovascular disease, NYHA Functional Class I-III heart failure. BMI calculated at the screening visit will be used to determine eligibility.

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: treatment with glucose-lowering agent(s) within 90 days before screening; personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men2); history of acute or chronic pancreatitis.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got VK2735 and who got the comparison, which limits bias.

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

As a double-blind VK2735 study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2026-11 with completion listed for 2028-07.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage change in body weight for participants 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.