VENTURE-1: IMPACT OF VK2735, A DUAL INCRETIN AGONIST, ON PREDICTED CARDIOVASCULAR DISEASE RISK
Author(s)
Karen C. Chung, MS, PharmD1, Summer Ji, MS2, Karen Modesto, MD2, Brian Lian, PhD2.
1Vice President, Viking Therapeutics, Inc., San Diego, CA, USA, 2Viking Therapeutics, Inc., San Diego, CA, USA.
1Vice President, Viking Therapeutics, Inc., San Diego, CA, USA, 2Viking Therapeutics, Inc., San Diego, CA, USA.
OBJECTIVES: Obesity is a chronic, systemic disease that contributes to the development of multiple chronic comorbidities, including CVD, the leading cause of mortality worldwide. Anti-obesity medications have the potential to prevent and/or manage obesity-related comorbidities. VK2735, a dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors, has demonstrated significant weight loss and improvements in cardiometabolic parameters in adults with obesity/overweight (Bays, 2026). Here, we examine the impact of weekly subcutaneous (SC) VK2735 on 10-year predicted risk of CVD, atherosclerotic CVD (ASCVD), and heart failure (HF).
METHODS: VENTURE (NCT06068946) was a Phase 2, 13-week, randomized, double-blind, placebo-controlled, parallel-arm, dose-finding study that evaluated once-weekly SC VK2735 in adults with obesity (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2) and ≥1 weight-related comorbidity. Participants (pts) with diabetes were excluded. Treatment groups were placebo, 2.5-, 5-, 10-, and 15-mg SC VK2735. Post hoc analyses assessing predicted 10-year CVD, ASCVD, and HF risk (Khan, 2024) at baseline and week 13 were conducted. Percent change in risk scores from baseline to week 13 was assessed using a mixed model of repeated measures.
RESULTS: A total of 176 pts were randomized, with 143 pts between 30-79 years with no history of CVD. Mean percent change (SE) from baseline to week 13 in 10-year predicted CVD, ASCVD, and HF risk scores in the VK2735 treatment group were -0.28% (3.50), -5.82% (3.08), and -15.82% (3.30), respectively, compared to +12.42% (7.21), +6.62% (6.34), and +7.38% (6.81) in the placebo group.
CONCLUSIONS: Following a 13-week treatment period with VK2735, average 10-year predicted CVD, ASCVD, and HF risk was lower in the VK2735 treatment group compared to both baseline and placebo in adults with obesity and overweight with ≥1 weight-related comorbidity. Ongoing 78-week Phase 3 trials in ~5,600 pts will further inform the impact of SC VK2735 on CVD risk.
METHODS: VENTURE (NCT06068946) was a Phase 2, 13-week, randomized, double-blind, placebo-controlled, parallel-arm, dose-finding study that evaluated once-weekly SC VK2735 in adults with obesity (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2) and ≥1 weight-related comorbidity. Participants (pts) with diabetes were excluded. Treatment groups were placebo, 2.5-, 5-, 10-, and 15-mg SC VK2735. Post hoc analyses assessing predicted 10-year CVD, ASCVD, and HF risk (Khan, 2024) at baseline and week 13 were conducted. Percent change in risk scores from baseline to week 13 was assessed using a mixed model of repeated measures.
RESULTS: A total of 176 pts were randomized, with 143 pts between 30-79 years with no history of CVD. Mean percent change (SE) from baseline to week 13 in 10-year predicted CVD, ASCVD, and HF risk scores in the VK2735 treatment group were -0.28% (3.50), -5.82% (3.08), and -15.82% (3.30), respectively, compared to +12.42% (7.21), +6.62% (6.34), and +7.38% (6.81) in the placebo group.
CONCLUSIONS: Following a 13-week treatment period with VK2735, average 10-year predicted CVD, ASCVD, and HF risk was lower in the VK2735 treatment group compared to both baseline and placebo in adults with obesity and overweight with ≥1 weight-related comorbidity. Ongoing 78-week Phase 3 trials in ~5,600 pts will further inform the impact of SC VK2735 on CVD risk.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
CO104
Topic
Clinical Outcomes, Epidemiology & Public Health, Study Approaches
Topic Subcategory
Relating Intermediate to Long-term Outcomes
Disease
Cardiovascular Disorders (including MI, Stroke, Circulatory), Diabetes/Endocrine/Metabolic Disorders (including obesity)