VK2735 for Weight Management Phase 3

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 who are obese (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2) with one or more weight related comorbid condition without Type 2 Diabetes.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Weight Loss Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Viking Clinical Site #1130, Mayagüez, Puerto Rico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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, New York Heart Association (NYHA) Functional Class I-III heart failure
BMI calculated at the Screening visit will be used to determine eligibility

Exclusion criteria

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 (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, mucosa 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)
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

Treatment and study plan

VK2735

Drug

VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly

Primary outcomes

Percentage change in body weight from baseline for participants receiving VK2735 after 78 weeks of treatment

Time frame: 78 Weeks

Secondary outcomes

Percentage of participants who achieve ≥5%, ≥10%, ≥15% and ≥20% body weight reduction after 78 weeks of treatment

Time frame: 78 Weeks

Sponsors and collaborators

Lead sponsor

Viking Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, 78-Week Efficacy and Safety Study of VK2735 Administered Subcutaneously for Weight Management in Participants Without Type 2 Diabetes Who Are Obese, or Overweight With at Least One Weight-related Comorbid Condition

Acronym: VANQUISH 1

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Aug 5, 2025
Registry last updated: Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting