VK2735 for Weight Management Phase 2 (Venture Oral Dosing)

Last updated: February 19, 2025
Sponsor: Viking Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Weight Loss

Diabetes Prevention

Treatment

Placebo

VK2735

Clinical Study ID

NCT06828055
VK2735-202
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years of age at the time of signing the informed consent.

  2. Body mass index (BMI) ≥30 kg/m2 OR ≥27 kg/m2 with at least one weight-relatedco-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

Exclusion Criteria:

  1. History of or current clinically significant medical or psychiatric 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. Current or past diagnosis of diabetes mellitus (including type 1, type 2,gestational)

  4. Current or past diagnosis of chronic pancreatitis

  5. Calcitonin ≥50 ng/L measured by central laboratory at screening (individuals withelevated calcitonin at initial screening may be re-screened)

  6. Any GLP-1 receptor agonist or GLP-1/GIP dual agonist within 6 months of Screening

  7. Any prescription or over-the-counter medications intended for weight loss within 6months of screening

Study Design

Total Participants: 280
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
December 18, 2024
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • Viking Clinical Site #111

    Peoria, Arizona 85381
    United States

    Active - Recruiting

  • Viking Clinical Site #105

    Lake Forest, California 96230
    United States

    Active - Recruiting

  • Viking Clinical Site #101

    Clearwater, Florida 33756
    United States

    Active - Recruiting

  • Viking Clinical Site #108

    Largo, Florida 33777
    United States

    Active - Recruiting

  • Viking Clinical Site #107

    Ocoee, Florida 34761
    United States

    Active - Recruiting

  • Viking Clinical Site #102

    Port Orange, Florida 32127
    United States

    Active - Recruiting

  • Viking Clinical Site #100

    Indianapolis, Indiana 46260
    United States

    Active - Recruiting

  • Viking Clinical Site #110

    Louisville, Kentucky 40213
    United States

    Active - Recruiting

  • Viking Clinical Site #114

    Marrero, Louisiana 70072
    United States

    Active - Recruiting

  • Viking Clinical Site #112

    Kansas City, Missouri 64131
    United States

    Active - Recruiting

  • Viking Clinical Site #109

    Saint Peters, Missouri 63303
    United States

    Active - Recruiting

  • Viking Clinical Site #113

    Butte, Montana 59701
    United States

    Active - Recruiting

  • Viking Clinical Site #103

    Knoxville, Tennessee 37909
    United States

    Active - Recruiting

  • Viking Clinical Site #104

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Viking Clinical Site #106

    San Antonio, Texas 78229
    United States

    Active - Recruiting

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