Oral VK2735 for Weight Management Phase 3 (SUNRISE 1)

NCT07868835 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: VK2735-304
• Study Type: interventional
• Target: 560
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Weight Loss

Keywords

Body Weight Changes; Body Weight; Weight Loss

Outcome Measures

Primary Outcomes (1)

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

  To demonstrate that VK2735 27.5mg, 35mg, and 55mg daily oral (each dose separately) is superior to placebo for percent change in body weight from baseline to week 68

  68 weeks

Study Arms (4)

Placebo Assignment

PLACEBO COMPARATOR

Placebo comparator orally once daily

Drug: Placebo comparator

Active Assignment (Dose 1)

EXPERIMENTAL

VK2735 27.5mg orally once daily

Drug: VK2735

Active Assignment (Dose 2)

EXPERIMENTAL

VK2735 35mg orally once daily

Drug: VK2735

Active Assignment (Dose 3)

EXPERIMENTAL

VK2735 55mg orally once daily

Drug: VK2735

Interventions

VK2735 DRUG

VK2735 Oral is a peptide GLP-1 and GIP dual agonist administered once daily

Active Assignment (Dose 1); Active Assignment (Dose 2); Active Assignment (Dose 3)

Placebo comparator DRUG

Placebo comparator administered orally once daily

Placebo Assignment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of or current clinically significant medical disorder that, in the opinion of the Investigator, does not support study participation
• Self-reported body weight change of 5% or more within 3 months of screening
• 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)
• 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
• 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

Sponsors & Collaborators

• Viking Therapeutics, Inc.: lead

MeSH Terms

Conditions

Weight Loss; Body Weight Changes; Body Weight

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hubert Chen, MD

CONTACT

8587044660; clinicaltrials@vikingtherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share