Oral VK2735 demonstrated early, progressive weight loss from Week 1 through Week 13 without a plateau
Dose-dependent weight loss observed across all VK2735 cohorts, with the highest dose achieving a mean reduction of up to 12.2% (26.6 lbs) from baseline at Week 13
Baseline characteristics in the ongoing Phase 3 VANQUISH-1 study of VK2735 in adults with obesity were also presented in a second poster at the conference
SAN DIEGO, May 12, 2026 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today presented additional data from its Phase 2 VENTURE-Oral Dosing trial evaluating the oral tablet formulation of VK2735 at the European Congress on Obesity (ECO) in Istanbul, Türkiye. VK2735 is a dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors, in development with subcutaneous and oral formulations for the potential treatment of various metabolic disorders.
The poster presented today at ECO 2026 highlighted key findings from previously reported trial data, including mean change from baseline in body weight throughout the 13-week treatment period and additional safety and tolerability data, for the Phase 2 study of orally administered VK2735. Participants receiving once-daily oral VK2735 demonstrated statistically significant, dose-dependent weight loss from baseline of up to 12.2% (26.6 lbs) at 13 weeks across all dose cohorts. Compared with placebo, doses >15 mg demonstrated dose-dependent and progressive weight loss starting early in treatment and continuing through the 13-week treatment window, with no plateau. Up to 97% of VK2735-treated participants achieved ≥5% weight loss, and up to 80% achieved ≥10%, compared with 10% and 5%, respectively, for placebo. VK2735 was well tolerated, with the vast majority of treatment-emergent adverse events (TEAEs) reported as mild or moderate in severity. These events typically occurred early in treatment and resolved with continued dosing. The study population was similar to patients typically encountered in clinical practice, with an average BMI of 37 and average age of 51 years. Similar to patients seen in clinical practice, there was a high prevalence of cardiometabolic risk factors, including pre-diabetes (54%). Across all dose cohorts, the male-to-female ratio ranged from 15:85 to 45:55.
"The Phase 2a VENTURE-Oral Dosing study results provide important data to inform the design of our upcoming oral Phase 3 registration studies. We observed compelling efficacy, a clear dose-response, and an encouraging tolerability profile through the 13-week treatment period in the study. All treated cohorts demonstrated statistically significant weight loss from baseline, and the full dataset presented at ECO provides a detailed picture of response over time," said Brian Lian, Ph.D., chief executive officer of Viking Therapeutics. "We are excited to move oral VK2735 into Phase 3 development as we believe it has the potential to become the first oral dual agonist of the GLP-1 and GIP receptors to reach the market. Together with the subcutaneous formulation, currently in the ongoing Phase 3 VANQUISH registration program, the oral tablet formulation represents a potentially differentiated treatment option by enabling patients to transition from injection to oral administration using the same active therapeutic agent. We look forward to initiating Phase 3 trials with the tablet later this year."
"From a clinical perspective, the early onset and continued progression of weight loss without plateau over 13 weeks is particularly compelling," said Parke Joseph Hedges, M.D., FACOG, Flourish Research, San Antonio, TX, a lead investigator in the VENTURE-Oral study. "We're seeing meaningful reductions emerge as early as Week 1 and continue across all dosing levels, alongside a tolerability profile that is manageable and consistent with dual agonist GLP-1/GIP receptors. The availability of a once-daily oral option that delivers this level of efficacy could represent an important and more accessible treatment option for patients for initial treatment as well as maintenance."
Highlights from Viking's poster titled Treatment with Oral VK2735 Results in Significant Weight Loss: The Randomized, Placebo-Controlled, Dose-Finding VENTURE-2 Study include:
- Early and progressive weight loss. Patients receiving VK2735 experienced statistically significant reductions in body weight compared with placebo, beginning as early as Week 1 at all doses greater than 15 mg, with continuous and progressive weight loss observed throughout the 13-week treatment period.
- No plateau observed. Weight loss trajectories demonstrate continued downward trends across all active dose levels through Week 13, supporting the potential for continued weight reduction with longer-duration treatment.
- Dose-dependent efficacy. Weight loss increased with escalating doses of VK2735, with the highest dose achieving a mean reduction of up to 12.2% of body weight from baseline at Week 13.
- Favorable tolerability profile. Among subjects receiving VK2735, the majority (98%) of reported drug-related TEAEs were categorized as mild or moderate in severity. Gastrointestinal-related events were the most commonly observed TEAEs and were consistent with dual agonist GLP-1/GIP receptors, typically occurring early in treatment and subsiding with continued dosing.
- Progressive titration enabled tolerability. Dose escalation in 30 mg increments enabled rapid progression to higher dose levels with an encouraging tolerability profile, and gastrointestinal events diminished over time. Lower starting doses and longer titration windows may further improve tolerability.
Change in Body Weight Following 13 Weeks of Daily Dosing with Oral VK2735
Dose Level1,2 | Placebo (n=40) | VK2735 15 mg (n=40) | VK2735 30 mg (n=40) | VK2735 60 mg (n=38) | VK2735 90 mg (n=39) | VK2735 120 mg (n=39) |
Mean baseline body weight (kg)3 | 105.2 kg | 99.0 kg | 102.9 kg | 102.8 kg | 103.4 kg | 101.9 kg |
Mean change from baseline body weight4,5 | -1.3 kg | -2.2 kg | -7.1 kg | -8.8 kg | -11.5 kg | -12.1 kg |
Mean percent change from baseline4,5 | -1.3 % | -2.3 % | -7.0 % | -8.7 % | -11.1 % | -12.2 % |
p-value vs. baseline5 | - | 0.0057 | <0.0001 | <0.0001 | <0.0001 | <0.0001 |
Placebo-adjusted mean percent change from baseline4,5 | - | -1.0 % | -5.7 % | -7.4 % | -9.8 % | -10.9 % |
p-value vs. placebo5 | - | - | <0.0001 | <0.0001 | <0.0001 | <0.0001 |
Percent reporting ≥ 10% weight loss | 5 % | 8 % | 35 % | 40 % | 59 % | 80 % |
p-value vs. placebo6 | - | - | <0.01 | 0.0017 | < 0.0001 | <0.0001 |
Notes: 1) Efficacy population, includes all randomized patients who received at least one dose of study drug and had a valid baseline and post-baseline body weight assessment. 2) Participants treated with VK2735 were titrated to final doses as indicated: 15 mg cohort = 15 mg x 13 weeks; 30 mg cohort = 30 mg x 13 weeks; 60 mg cohort = 30 mg x 2 weeks, 60 mg x 11 weeks; 90 mg cohort = 30 mg x 2 weeks, 60 mg x 2 weeks, 90 mg x 9 weeks; 120 mg cohort = 30 mg x 2 weeks, 60 mg x 2 weeks, 90 mg x 2 weeks, 120 mg x 7 weeks. 3) All enrolled participants were required to have baseline BMI ≥30 kg/m2 or BMI≥27 kg/m2 with at least one weight-related comorbid condition. 4) Least squares mean. 5) Two-sided t-test using mixed model for repeated measures. 6) Logistic regression model with treatment as factor and baseline weight as covariate. |
Poster Presentation Details:
Publication Number: PO4.260
Title: Treatment with Oral VK2735 Results in Significant Weight Loss: The Randomized, Placebo-Controlled, Dose-Finding VENTURE-2 Study
Presented by: Karen Modesto, M.D., Vice President, Clinical Development
Date/Time: On display May 12-15, with poster networking session on May 14 from 18 – 19:15 Turkish Time
Location: Poster area at Level B5, Istanbul Congress Center
Viking also presented a second poster at ECO today highlighting the design and enrollment demographics of the ongoing Phase 3 VANQUISH-1 study of subcutaneous VK2735 in adults with obesity or who are overweight and have at least one weight-related comorbidity.
Poster Presentation Details:
Publication Number: PO4.278
Title: VANQUISH-1: Phase 3 Trial With Enrollment of Diverse Population to Test Efficacy of Subcutaneous VK2735 in Adult Participants with Obesity or Overweight with Weight Related Comorbidities
Presented by: Karen Modesto, M.D., Vice President, Clinical Development
Date/Time: On display May 12-15, with poster networking session on May 14 from 18 – 19:15 Turkish Time
Location: Poster area at Level B5, Istanbul Congress Center
Copies of these poster presentations are available in the Publications section of Viking's website at www.vikingtherapeutics.com/pipeline/publications/.
About the Phase 2 VENTURE-Oral Trial
The Phase 2 VENTURE-Oral Dosing Trial was a randomized, double-blind, placebo-controlled multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK2735 dosed as an oral tablet once daily for 13 weeks. The trial enrolled 280 adults who are obese (BMI ≥30 kg/m2), or adults who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition. Enrolled patients were evenly randomized to one of six dosing arms or placebo. The primary endpoint of the study was the percent change in body weight from baseline after 13 weeks of treatment, while secondary and exploratory endpoints evaluated a range of additional safety and efficacy measures.
About VK2735
VK2735 is a novel dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors in development for the treatment of metabolic disorders, including obesity. The compound is being evaluated in both oral and subcutaneous formulations.
About GLP-1 and Dual GLP-1/GIP Agonists
Activation of the glucagon-like peptide 1 (GLP-1) receptor has been shown to decrease glucose, reduce appetite, lower body weight, and improve insulin sensitivity in patients with type 2 diabetes, obesity, or both. Semaglutide is a GLP-1 receptor agonist that has been approved by the U.S. Food and Drug Administration and is currently marketed in various dosage strengths and forms as Ozempic®, Rybelsus®, and Wegovy®. More recently, research efforts have explored the potential co-activation of the glucose-dependent insulinotropic peptide (GIP) receptor as a means of enhancing the therapeutic benefits of GLP-1 receptor activation. Tirzepatide is a dual GLP-1/GIP receptor agonist that has been approved by the U.S. Food and Drug Administration and is currently marketed in various dosage strengths and forms as Mounjaro® and Zepbound®.
About Viking Therapeutics
Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders. Viking's research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients' lives. Viking's clinical programs include VK2735, a novel dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors for the potential treatment of various metabolic disorders. The company is evaluating its subcutaneous formulation of VK2735 in a Phase 3 obesity program that includes two Phase 3 clinical trials (VANQUISH-1 and VANQUISH-2). Data from a Phase 1 and a Phase 2 trial evaluating subcutaneous VK2735 demonstrated an encouraging safety and tolerability profile as well as positive signs of clinical benefit. Concurrently, the company is evaluating an oral formulation of VK2735 in a Phase 2 trial in obesity. Viking is also developing VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders. The compound successfully achieved both the primary and secondary endpoints in a Phase 2b study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis. In a Phase 2a trial for the treatment of non-alcoholic fatty liver disease (NAFLD) and elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content compared with patients who received placebo. The company's newest program is evaluating a series of internally developed dual amylin and calcitonin receptor agonists (or DACRAs) for the treatment of obesity and other metabolic disorders. In the rare disease space, Viking is developing VK0214, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the potential treatment of X-linked adrenoleukodystrophy (X-ALD). In a Phase 1b clinical trial in patients with the adrenomyeloneuropathy (AMN) form of X-ALD, VK0214 was shown to be safe and well-tolerated, while driving significant reductions in plasma levels of very long-chain fatty acids (VLCFAs) and other lipids, as compared to placebo.
For more information about Viking Therapeutics, please visit www.vikingtherapeutics.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding Viking Therapeutics, Inc., under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its clinical and preclinical development programs, anticipated timing for reporting clinical data and cash resources. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with the success, cost and timing of Viking's product candidate development activities and clinical trials, including those for VK2735, VK0214, VK2809, and the company's other incretin and other receptor agonists; risks that prior clinical and preclinical results may not be replicated; risks regarding regulatory requirements; and other risks that are described in Viking's most recent periodic reports filed with the Securities and Exchange Commission including Viking's Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent Quarterly Reports on Form 10-Q, including the risk factors set forth in those filings. These forward-looking statements speak only as of the date hereof. Viking disclaims any obligation to update these forward-looking statements except as required by law.
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