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Completed

NCT Number: NCT06828055

VK2735 for Weight Management Phase 2 (Venture Oral Dosing)

This is a phase 2, 13-week randomized, double-blind, placebo-controlled, parallel arm dose-finding study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of VK2735 Oral Formulation in adults who are obese (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition.

VK2735 or matched placebo will be administered once daily.

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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 2

Primary location

Viking Clinical Site #111, Peoria, Arizona, United States

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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), and BMI <50 kg/m2
  • Weight-related co-morbid conditions include hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease.
  • BMI calculated at the Screening visit will be used to determine eligibility.

Exclusion criteria

  • History of or current clinically significant medical or psychiatric 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
  • Current or past diagnosis of diabetes mellitus (including type 1, type 2, gestational)
  • Current or past diagnosis of chronic pancreatitis
  • Calcitonin ≥50 ng/L measured by central laboratory at screening (individuals with elevated calcitonin at initial screening may be re-screened)
  • Any GLP-1 receptor agonist or GLP-1/GIP dual agonist within 6 months of Screening
  • Any prescription or over-the-counter medications intended for weight loss within 6 months of screening

Treatment and study plan

Placebo

Drug

Matching Placebo to VK2735

VK2735

Drug

Active Treatment

Primary outcomes

  1. Percent (relative) change from baseline in body weight after 13 weeks of treatment

    Time frame: 13 Weeks

    To measure the efficacy of oral VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition

Secondary outcomes

  1. Proportion of Subjects losing ≥5% and ≥10% of baseline weight at Week 13. Observed and change from baseline in body weight (kg) after 13 weeks of treatment

    Time frame: 13 Weeks

    To measure the efficacy of oral VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition

Other outcomes

  1. Incidence of Treatment-emergent Adverse Events, incidence of Treatment-Emergent Serious Adverse Events and incidence of Adverse Events of Special Interest

    Time frame: 13 Weeks

    To evaluate the safety and tolerability of oral VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition

Sponsors and collaborators

Lead sponsor

Viking Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase 2 Randomized, Double-Blind, Placebo-Controlled, 13-week Dose Finding Study of VK2735 Oral Formulation for Weight Management in Subjects Who Are Obese, or Overweight With at Least One Weight-related Comorbid Condition

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 14, 2025
Registry last updated
Oct 6, 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.

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