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Delfa

← All trials/NCT07868835

Not yet recruitingPhase 3

Oral VK2735 for Weight Management Phase 3 (SUNRISE 1)

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, 68-Week Efficacy and Safety Study of VK2735 Administered Orally for Weight Management in Participants Without Type 2 Diabetes Mellitus Who Are Obese, or Overweight With at Least One Weight-related Comorbid Condition

Asset

VK2735

Subcutaneous · GLP-1 / GIP dual

Listed sites

0

Recruiting sites

-

Estimated enrollment

560

Study population

-

Eligibility highlights

•BMI ≥30

Primary endpoint

•Body weight for participants receiving VK2735 orally once daily

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07868835
Org study IDVK2735-304

Timeline

Milestones

Study first posted2026-10-09actual
Last update posted2026-10-16actual
Study start2026-11estimated (month precision)
Primary completion2028-07estimated (month precision)
Study completion2028-08estimated (month precision)

Assets

Investigational agents

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Age ≥18 years of age at the time of signing the informed consent.

2. 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.

Exclusion criteria

1. History of or current clinically significant medical disorder that, in the opinion of the Investigator, does not support study participation

2. Self-reported body weight change of 5% or more within 3 months of screening

3. Have a prior or planned surgical treatment for obesity such as a gastric sleeve, lap band or any form of bariatric surgery (excluding liposuction or abdominoplasty if performed >1 year prior to screening)

4. Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to screening (such as mucosal ablation, gastric artery embolization, intragastric balloon, duodenal-jejunal endoluminal line)

5. Current or past diagnosis of diabetes mellitus (including type 1, type 2, except gestational diabetes). If a participant has had gestational diabetes, they are allowed to be enrolled as long as the glycemic status has returned to normal levels after 12 months of completion of pregnancy

6. Treatment with glucose-lowering agent(s) within 90 days before screening

7. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)

8. History of acute or chronic pancreatitis

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Weight & body composition

1 endpoint
Primary/protocol endpoint

Percentage change in body weight for participants receiving VK2735 orally once daily

Time frame:68 weeks

percent change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.