VK2735 for Weight Management Phase 2 (VENTURE)

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

This is a phase 2, 13-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of VK2735 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 weekly.

Study Overview

• Status: Completed
• Conditions: Weight Loss
• Intervention / Treatment: Biological: Placebo; Biological: VK2735

• Study Type: Interventional
• Enrollment (Actual): 176
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Viking Clinical Site #119
  • California
    • Long Beach, California, United States, 90815
      • Viking Clinical Site #114
    • Los Angeles, California, United States, 90057
      • Viking Clinical Site #110
    • Tustin, California, United States, 92780
      • Viking Clinical Site #113
  • Florida
    • Clearwater, Florida, United States, 33756
      • Viking Clinical Site #116
    • Clearwater, Florida, United States, 33761
      • Viking Clinical Site #106
    • Jacksonville, Florida, United States, 32216
      • Viking Clinical Site #112
    • Ocoee, Florida, United States, 34761
      • Viking Clinical Site #105
    • Port Orange, Florida, United States, 32127
      • Viking Clinical Site #107
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Viking Clinical Site #104
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • Viking Clinical Site #103
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Viking Clinical Site #109
  • Missouri
    • Kansas City, Missouri, United States, 64131
      • Viking Clinical Site #102
  • Montana
    • Butte, Montana, United States, 59701
      • Viking Clinical Site #111
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Viking Clinical Site #108
  • Texas
    • Austin, Texas, United States, 78705
      • Viking Clinical Site #101
    • Austin, Texas, United States, 78731
      • Viking Clinical Site #118
    • Phoenix, Texas, United States, 85210
      • Viking Clinical Site #100
    • San Antonio, Texas, United States, 78229
      • Viking Clinical Site #115
    • San Antonio, Texas, United States, 78229
      • Viking Clinical Site #117

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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-related co-morbid condition (treated or untreated), and BMI <50 kg/m2

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 ≥20 ng/L measured by central laboratory at screening (individuals with elevated 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 6 months of screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: VK2735 (Placebo); Placebo	Biological: Placebo; Placebo comparator
Experimental: VK2735 (Dose #1); VK2735 is a peptide GLP-1 and GIP dual agonist	Biological: VK2735; VK2735 is a peptide GLP-1 and GIP dual agonist
Experimental: VK2735 (Dose #2); VK2735 is a peptide GLP-1 and GIP dual agonist	Biological: VK2735; VK2735 is a peptide GLP-1 and GIP dual agonist
Experimental: VK2735 (Dose #3); VK2735 is a peptide GLP-1 and GIP dual agonist	Biological: VK2735; VK2735 is a peptide GLP-1 and GIP dual agonist
Experimental: VK2735 (Dose #4); VK2735 is a peptide GLP-1 and GIP dual agonist	Biological: VK2735; VK2735 is a peptide GLP-1 and GIP dual agonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent (relative) change from baseline to Week 13 in body weight	To measure the efficacy of VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition	13 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects losing ≥5% and ≥10% of baseline weight at Week 13	To measure the efficacy of VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition	13 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent adverse events (TEAEs), TESAEs, AESI	To evaluate the safety and tolerability of VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition	13 weeks

Collaborators and Investigators

• Sponsor: Viking Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2023
• Primary Completion (Actual): February 27, 2024
• Study Completion (Actual): April 2, 2024

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Overweight; Obese
• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: VK2735-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No