Oral VK2735 for Weight Management in Adults With Type 2 Diabetes Mellitus Phase 3 (SUNRISE 2)

NCT07868939 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: VK2735-305
• 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 ≥ 27 kg/m2) adults with Type 2 Diabetes Mellitus.

Conditions

Weight Loss

Keywords

body weight changes; body weight; weight loss

Outcome Measures

Primary Outcomes (1)

• Percent change in body weight for participants with type 2 diabetes mellitus 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 Oral

Active Assignment (Dose 2)

EXPERIMENTAL

VK2735 35mg orally once daily

Drug: VK2735 Oral

Active Assignment (Dose 3)

EXPERIMENTAL

VK2735 55mg orally once daily

Drug: VK2735 Oral

Interventions

VK2735 Oral 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) ≥ 27 kg/m2
• Have Type 2 Diabetes Mellitus according to the American Diabetes Association (See Section 12.5), with HbA1c ≥ 7% to ≤ 11% at screening, on stable therapy for the last 3 months prior to Screening. Participants with HbA1c between 6.5%-6.9% or 11.0%-11.5% are allowed to have a single HbA1c retesting to confirm eligibility. Type 2 Diabetes Mellitus may be treated with diet/exercise alone or any oral glycemic-lowering agent (as per local labeling), EXCEPT for amylin analogues or dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1R agonists or dual GLP-1/ glucose-dependent insulinotropic polypeptide (GIP) receptor agonists.

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 (except for 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)
• Have Type 1 Diabetes Mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except Type 2 Diabetes Mellitus (T2DM)
• Have had 1 or more episodes of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 6 months of screening
• Note: Severe hypoglycemia episodes should be considered when severe cognitive impairment requiring the assistance of another person occurs and the administration of carbohydrate, glucagon, or other resuscitative actions are required. Blood glucose (BG) measurements may not be available during such an event, but neurological recovery attributable to the restoration of BG to normal is considered sufficient evidence that the event was induced by a low BG concentration. If BG measurements are available, the levels associated with severe hypoglycemia are BG \< 54 mg/dL.
• Have at least 2 confirmed fasting self-monitoring blood glucose (SMBG) values \> 270 mg/dL (on 2 non-consecutive days) within 4 weeks prior to randomization
• Have non-proliferative diabetic retinopathy that requires acute treatment OR diabetic macular edema OR proliferative diabetic retinopathy identified during a dilated fundoscopy examination performed within 3 months of screening. Please see Section 7.6.
• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
• History of acute or chronic pancreatitis
• Thyroid disease that is not controlled (Thyroid stimulating hormone (TSH) outside normal range by central lab at screening; one repetition during screening is allowed). Participants with previous history of partial/total thyroidectomy or hypothyroidism may be included, provided their hormone replacement dose has been stable for 3 months prior to screening.

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 16, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share