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VK2735 for Weight Management Type 2 Diabetes Phase 3 (VANQUISH 2) | Clinical Trials | Clareo Health

RECRUITINGPHASE3

VK2735 for Weight Management Type 2 Diabetes Phase 3 (VANQUISH 2)

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, 78-Week Efficacy and Safety Study of VK2735 Administered Subcutaneously for Weight Management in Participants With Type 2 Diabetes Who Are Obese, or Overweight

NCT07104383•Viking Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

This is a phase 3, multicenter, 78-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the weight loss efficacy as well as safety, tolerability, pharmacodynamic effects, and pharmacokinetics of VK2735 in adults with Type 2 Diabetes who are obese or overweight

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥18 years of age at the time of signing the informed consent
•2. Body mass index (BMI) ≥27 kg/m2
•3. Have Type 2 Diabetes Mellitus according to the American Diabetes Association with HbA1c ≥ 7% to ≤ 11% at screening, on stable therapy for the last 3 months prior to Screening. 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

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 (except for 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. Have Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except Type 2 diabetes mellitus (T2DM)
•6. 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
•7. 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
•8. Have proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment
•9. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
+2 more criteria

Locations (134)

Viking Clinical Site #2037

Birmingham, Alabama, United States

Viking Clinical Site #2064

Birmingham, Alabama, United States

Viking Clinical Site #2128

Huntsville, Alabama, United States

Viking Clinical Site #2081

Mobile, Alabama, United States

Viking Clinical Site #2005

Chandler, Arizona, United States

Viking Clinical Site #2017

Flagstaff, Arizona, United States

Viking Clinical Site #2018

Peoria, Arizona, United States

Viking Clinical Site #2135

Scottsdale, Arizona, United States

Viking Clinical Site #2019

Tucson, Arizona, United States

Viking Clinical Site #2036

Little Rock, Arkansas, United States

Key Dates

Start Date

June 23, 2025

Primary Completion Date

July 1, 2027

Completion Date

August 1, 2027

Last Updated

February 13, 2026

Enrollment

1,100

ESTIMATED participants

Conditions

Weight Loss

Interventions

VK2735

DRUG

Contacts

Maris Johnson

CONTACT

Clinicaltrials@vikingtherapeutics.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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VK2735 for Weight Management Type 2 Diabetes Phase 3 (VANQUISH 2)

Inclusion Criteria

Exclusion Criteria

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