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
Lead sponsor
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
Timeline
Milestones
Assets
Investigational agents
Who can enroll
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).
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 endpointPercentage change in body weight for participants receiving VK2735 orally once daily
Time frame:68 weeks
percent change from baseline, improvement
Provenance
Sources
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.