VK2735 Phase 2 Trial Delivers Strong Efficacy Data in Obesity Management with Sustained Weight Loss Through 13-Week Treatment Period

Viking Therapeutics has released encouraging findings from its Phase 2 VENTURE trial evaluating VK2735, a dual-acting therapeutic designed to target two crucial metabolic pathways simultaneously. The clinical trial achieved all primary and secondary objectives, marking a significant milestone in the company’s pipeline for metabolic disorder treatment.

Trial Achievement and Weight Loss Results

The VENTURE trial enrolled 176 adults with obesity (BMI ≥30 kg/m²) or overweight individuals (BMI ≥27 kg/m²) with weight-related comorbidities over a 13-week treatment window. Participants receiving VK2735 demonstrated progressive reductions in body weight compared to the placebo group, with no plateau observed at the trial’s conclusion—a noteworthy finding suggesting extended treatment could yield additional benefits.

By Week 13, patients treated with VK2735 exhibited dose-dependent responses. At the highest dose level, participants achieved a mean weight loss of 14.7% from baseline, representing a placebo-adjusted reduction of 13.1%. The lowest tested dose (2.5 mg weekly) produced a 9.1% placebo-adjusted weight loss, while intermediate doses (5 mg and 10 mg) demonstrated 9.2% and 11.3% placebo-adjusted reductions, respectively. All dose-response differences reached statistical significance beginning at Week 1 and persisting throughout the entire treatment duration.

Proportion Achieving Clinically Meaningful Weight Loss

A secondary endpoint evaluated the proportion of patients achieving at least 10% weight loss—a threshold often associated with meaningful metabolic and health improvements. The data revealed compelling dose-response relationships. Participants receiving the highest VK2735 dose attained an 88% rate of ≥10% weight loss compared to just 4% in the placebo group. Even the lowest active dose achieved a 39% responder rate. The 5 mg and 10 mg dose cohorts demonstrated 62% and 70% achievement rates, respectively, all statistically significant versus placebo.

Safety Profile and Gastrointestinal Tolerability

VK2735 demonstrated an acceptable safety and tolerability profile across the 13-week period. Treatment discontinuation rates remained balanced between active treatment and placebo cohorts (13% versus 14%), suggesting patients could generally tolerate the medication. Among VK2735-treated participants, 92% of drug-related adverse events were characterized as mild or moderate in severity.

Gastrointestinal side effects represented the primary safety consideration. Nausea occurred in 43% of VK2735-treated participants compared to 20% receiving placebo. However, the majority of nausea cases (68% of affected patients) were mild in intensity, with 32% moderate and none severe. Vomiting was reported by 18% of VK2735-treated patients versus 0% in the placebo arm. Notably, gastrointestinal symptom frequency decreased substantially after initial dosing, with weekly nausea rates remaining below 5% following the first treatment week across all VK2735 cohorts.

Other gastrointestinal events included diarrhea (20% of VK2735 patients), constipation (26%), and decreased appetite (16%), with these events generally mild to moderate and concentrated in the early treatment phase. Importantly, 95% of all gastrointestinal treatment-emergent adverse events were classified as mild or moderate, contributing to the overall favorable tolerability assessment.

One serious adverse event—a dehydration case attributed to study medication—occurred in the VK2735-treated population. This single occurrence underscores the importance of patient counseling regarding adequate fluid intake during therapy.

Clinical Significance and Development Path

The dual mechanism of VK2735 represents a refinement in understanding how simultaneous activation of GLP-1 and GIP pathways may enhance therapeutic outcomes. This dual-agonist approach builds upon the established efficacy of GLP-1 receptor activation, which independently reduces glucose levels, suppresses appetite, and improves insulin sensitivity. The addition of GIP receptor activation appears to amplify these metabolic benefits, as evidenced by the weight reduction magnitudes observed in this trial.

The absence of a weight loss plateau at 13 weeks suggests that extended treatment duration may yield further improvements, potentially exceeding the reductions demonstrated in this trial. This finding carries clinical implications for patients requiring substantial weight loss to achieve meaningful health improvements.

Participant Baseline Characteristics and Study Design

The VENTURE trial employed a randomized, double-blind, placebo-controlled methodology across five parallel cohorts: placebo (n=34), VK2735 2.5 mg (n=35), VK2735 5 mg (n=35), VK2735 10 mg (n=35), and VK2735 15 mg (n=35). Participants followed dose-escalation protocols, with the 15 mg cohort titrating from 5 mg over a 12-week period before reaching the target dose during Week 13.

Mean baseline body weights ranged from 98.3 kg to 105.3 kg across cohorts, ensuring comparable populations. All enrolled participants met obesity or overweight-with-comorbidity criteria, reflecting real-world patient populations most likely to benefit from anti-obesity therapeutics.

Future Development and Regulatory Path Forward

On the basis of these encouraging Phase 2 results, Viking Therapeutics plans to engage with regulatory authorities to discuss next developmental steps for VK2735. The company simultaneously continues evaluation of an oral formulation in Phase 1 testing, with data expected later in the current quarter. This parallel development track suggests potential future flexibility in dosing options and patient convenience.

The Phase 2 VENTURE results provide a foundation for advancing VK2735 into larger, longer-duration Phase 3 trials anticipated later in the year. These confirmatory studies will further establish the drug’s role in the therapeutic landscape for obesity management and related metabolic disorders.