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NCT07868835Not 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

Source: ClinicalTrials.gov · Last updated 16 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
560 (estimated)
First submitted
5 Oct 2026
Start date
Nov 2026
Primary completion date
Jul 2028
Lead sponsor
Viking Therapeutics, Inc.
NCT number
NCT07868835

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 560
  • From Nov 2026 to the primary completion date, Jul 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)
  • 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)

Other illness

  • History of or current clinically significant medical disorder that, in the opinion of the Investigator, does not support study participation
  • 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
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
  • History of acute or chronic pancreatitis

Lab values

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

Other

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

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.