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
1 other identifier
interventional
176
1 country
20
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2023
Shorter than P25 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 31, 2023
CompletedFirst Submitted
Initial submission to the registry
September 28, 2023
CompletedFirst Posted
Study publicly available on registry
October 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 2, 2024
CompletedFebruary 12, 2025
December 1, 2024
6 months
September 28, 2023
February 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Proportion of Subjects losing ≥5% and ≥10% of baseline weight at Week 13
13 weeks
Other Outcomes (1)
Incidence of treatment-emergent adverse events (TEAEs), TESAEs, AESI
13 weeks
Study Arms (5)
VK2735 (Placebo)
PLACEBO COMPARATORPlacebo
VK2735 (Dose #1)
EXPERIMENTALVK2735 is a peptide GLP-1 and GIP dual agonist
VK2735 (Dose #2)
EXPERIMENTALVK2735 is a peptide GLP-1 and GIP dual agonist
VK2735 (Dose #3)
EXPERIMENTALVK2735 is a peptide GLP-1 and GIP dual agonist
VK2735 (Dose #4)
EXPERIMENTALVK2735 is a peptide GLP-1 and GIP dual agonist
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 ≥20 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Viking Clinical Site #119
Birmingham, Alabama, 35235, United States
Viking Clinical Site #114
Long Beach, California, 90815, United States
Viking Clinical Site #110
Los Angeles, California, 90057, United States
Viking Clinical Site #113
Tustin, California, 92780, United States
Viking Clinical Site #116
Clearwater, Florida, 33756, United States
Viking Clinical Site #106
Clearwater, Florida, 33761, United States
Viking Clinical Site #112
Jacksonville, Florida, 32216, United States
Viking Clinical Site #105
Ocoee, Florida, 34761, United States
Viking Clinical Site #107
Port Orange, Florida, 32127, United States
Viking Clinical Site #104
Indianapolis, Indiana, 46260, United States
Viking Clinical Site #103
Louisville, Kentucky, 40213, United States
Viking Clinical Site #109
Marrero, Louisiana, 70072, United States
Viking Clinical Site #102
Kansas City, Missouri, 64131, United States
Viking Clinical Site #111
Butte, Montana, 59701, United States
Viking Clinical Site #108
Knoxville, Tennessee, 37920, United States
Viking Clinical Site #101
Austin, Texas, 78705, United States
Viking Clinical Site #118
Austin, Texas, 78731, United States
Viking Clinical Site #100
Phoenix, Texas, 85210, United States
Viking Clinical Site #115
San Antonio, Texas, 78229, United States
Viking Clinical Site #117
San Antonio, Texas, 78229, United States
Related Publications (1)
Bays HE, Toth P, Alkhouri N, Pullman J, Freilich B, Neutel J, Ji S, Stubbe S, Hedges P, Lian B. Weekly Subcutaneous VK2735, a GIP/GLP-1 Receptor Dual Agonist, for Weight Management: Phase 2, Randomized, 13-Week VENTURE Study. Obesity (Silver Spring). 2026 Jan 8. doi: 10.1002/oby.70106. Online ahead of print.
PMID: 41508550DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2023
First Posted
October 5, 2023
Study Start
August 31, 2023
Primary Completion
February 27, 2024
Study Completion
April 2, 2024
Last Updated
February 12, 2025
Record last verified: 2024-12