Viking Therapeutics Announces Initiation of VK2735 Oral Phase 3 Clinical Program in Patients with Obesity

The new oral studies will assess weight change over 68 weeks, following a Phase 2 study that achieved its primary and secondary endpoints.

Rhea-AI Summary

Viking Therapeutics (VKTX) has initiated its SUNRISE Phase 3 clinical program to evaluate oral VK2735 for obesity. SUNRISE-1 and SUNRISE-2 each target 560 adults, without and with type 2 diabetes, respectively. The placebo-controlled trials will assess once-daily treatment over 68 weeks, with percent change in body weight from baseline as the primary endpoint.

The Phase 2 VENTURE-Oral study achieved its primary and secondary endpoints. Mean body weight reductions reached up to 12.2% after 13 weeks; 98% of reported drug-related adverse events arising during treatment were mild or moderate. Gastrointestinal events were the most common. Viking is also conducting an oral maintenance dosing trial. Its injectable Phase 3 VANQUISH-1 and VANQUISH-2 studies are fully enrolled, with approximately 4,500 and 1,000 adults, respectively, evaluating weekly treatment over 78 weeks.

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Positive

• Major pointPhase 2 VENTURE-Oral achieved its primary and secondary endpoints.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Oral VK2735 Phase 3 SUNRISE program initiated, with two studies each targeting 560 adults.
• Moderate pointInjectable VANQUISH-1 is fully enrolled with approximately 4,500 adults without type 2 diabetes.
• Moderate pointInjectable VANQUISH-2 is fully enrolled with approximately 1,000 adults with type 2 diabetes.
• Minor pointPhase 2 mean body weight reductions reached up to 12.2% from baseline after 13 weeks.

7 minor points

• Minor pointPhase 2 doses greater than 15 mg showed statistically significant differences versus placebo from Week 1 onward.
• Minor pointPhase 2 weight loss progressed through Week 13, with no evidence of a plateau.
• Minor pointPhase 2 patients achieving at least 5% weight loss reached up to 97%, versus 10% with placebo.
• Minor pointPhase 2 patients achieving at least 10% weight loss reached up to 80%, versus 5% with placebo.
• Minor pointPhase 2 reported drug-related adverse events were 98% mild or moderate.
• Minor pointPhase 2 gastrointestinal events generally subsided with continued dosing across VK2735 treatment cohorts.
• Minor pointVK2735 maintenance dosing trial is currently underway.

Negative

• Minor pointGastrointestinal events were the most commonly observed adverse events arising during treatment in Phase 2.

News Explained

Viking says its ongoing VK2735 maintenance-dosing trial will evaluate daily oral doses, monthly or every-other-week subcutaneous doses, and placebo; this corrects the October 6, 2026 release’s description of “weekly oral doses” and clarifies that the trial includes injectable options.

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SUNRISE -1 and SUNRISE-2 Studies to Evaluate Oral VK2735 in Obese Adults with and without Type 2 Diabetes 

SAN DIEGO, Oct. 14, 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 announced the initiation of the SUNRISE Phase 3 clinical program for oral VK2735, the company's dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. VK2375 is being developed in both oral and subcutaneous formulations for the potential treatment of various metabolic disorders such as obesity.

The SUNRISE Phase 3 program includes two studies evaluating oral VK2735: one in adults with obesity and another in obese or overweight adults with type 2 diabetes. Each study is a randomized, double-blind, placebo-controlled, multicenter trial designed to assess the efficacy and safety of VK2735, with patients receiving once-daily oral VK2735 for 68 weeks. SUNRISE-1 and SUNRISE-2 will each target enrollment of 560 adults. SUNRISE-1 will include obese (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2) adults without type 2 diabetes who have at least one weight-related comorbidity. SUNRISE-2 will enroll adults with type 2 diabetes who are obese or overweight. Participants in both trials will be randomly assigned to one of four treatment groups receiving once-daily VK2735 doses of 27.5 mg, 35 mg, 55 mg, or placebo.

The primary endpoint of both trials is the percent change in body weight from baseline for participants receiving oral VK2735 as compared to placebo after 68 weeks of treatment. Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy metrics, including the percentage of patients who achieve ≥ 5%, ≥ 10%, ≥ 15% or ≥ 20% body weight reduction from baseline. 

"Advancing the oral tablet formulation of VK2735 into Phase 3 is an exciting step toward expanding Viking's portfolio of therapeutic treatments for obesity," said Brian Lian, Ph.D., chief executive officer of Viking. "Oral VK2735 represents the most advanced oral dual GLP-1/GIP agonist in clinical development and has the potential to be positioned as either an induction therapy or in the maintenance setting, increasing the treatment options available to patients and clinicians. Obesity is a chronic disease that often requires long-term treatment, making convenience and ease of use important considerations for supporting patients throughout their treatment journey. We believe a once-daily oral therapy could offer a flexible dosing option that may support improved treatment adherence over time. Oral VK2735, together with our subcutaneous formulation, which is currently in the Phase 3 VANQUISH registration program, could provide clinicians and patients with greater choice in selecting an approach to weight loss and long-term management that best meets the needs of individual patients."

In 2025, Viking announced positive top-line results from the Phase 2 VENTURE-Oral Dosing study of the oral tablet formulation of VK2735 in obesity. The study successfully achieved its primary and secondary endpoints, with patients receiving once-daily oral VK2735 demonstrating clinically meaningful reductions in body weight compared with placebo. For the primary endpoint after 13 weeks of treatment, patients receiving oral VK2735 demonstrated statistically significant, dose-dependent reductions in mean body weight from baseline of up to 12.2%. Differences compared with placebo were statistically significant for all doses greater than 15 mg starting at Week 1 and were maintained throughout the study. Weight loss was progressive through Week 13 with no evidence of a plateau. Up to 97% of patients receiving oral VK2735 achieved at least 5% weight loss, and up to 80% achieved at least 10% weight loss, compared with 10% and 5% of patients receiving placebo, respectively.

Oral VK2735 also demonstrated encouraging safety and tolerability in the Phase 2 VENTURE-Oral study, with 98% of reported drug-related treatment-emergent adverse events (TEAEs) characterized as mild or moderate. Gastrointestinal (GI)-related events were the most commonly observed TEAEs and were consistent with the known effects of dual GLP-1/GIP receptor agonists. Across VK2735 treatment cohorts, GI-related events generally occurred early in treatment and subsided with continued dosing. Progressive dose escalation in 30 mg increments enabled participants to advance rapidly to higher dose levels while maintaining an encouraging tolerability profile.

In addition to the SUNRISE Phase 3 program, Viking is currently conducting a maintenance dosing trial of oral VK2735 and two Phase 3 studies evaluating subcutaneous VK2735 (VANQUISH-1 and VANQUISH-2). The VANQUISH trials are randomized, double-blind, placebo-controlled, multicenter trials designed to assess the efficacy and safety of subcutaneous VK2735 dosed weekly for 78 weeks. The VANQUISH-1 study is fully enrolled with approximately 4,500 adults who do not have type 2 diabetes and who have obesity (BMI ≥30 kg/m²) or are overweight (BMI ≥27 kg/m²) with at least one weight-related co-morbid condition. The VANQUISH-2 study is also fully enrolled with approximately 1,000 adults with type 2 diabetes who have obesity or are overweight. Patients in both trials are being randomized to one of four weekly VK2735 treatment arms of 7.5 mg, 12.5 mg, 17.5 mg, or placebo.

Correction Note: The company's press release issued on October 6, 2026, entitled, Viking Therapeutics Announces Initiation of VK2735 Oral Maintenance Dosing Clinical Trial in Patients with Obesity, incorrectly stated that the trial would be evaluating, "weekly oral doses." The trial will be evaluating maintenance dosing options including daily oral doses, monthly subcutaneous doses, every-other-week subcutaneous doses, or placebo. 

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, Inc.

Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company advancing a next-generation portfolio of therapies for obesity and metabolic disease. Guided by deep expertise in metabolic biology and rigorous science, Viking is developing innovative treatments to help people achieve meaningful, lasting health improvements by treating obesity first. The company's lead program, VK2735, is a dual glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist in development in both subcutaneous and oral formulations for obesity. VK2735 is currently being evaluated in Phase 3 clinical studies for obesity, along with maintenance dosing strategies designed to support long-term weight management. Viking is also advancing additional obesity programs, including VK3019, an amylin receptor agonist, VK2809, an orally available thyroid hormone receptor beta agonist for metabolic and liver disease, and VK0214 for the rare genetic disorder X-linked adrenoleukodystrophy (X-ALD).

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 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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SOURCE Viking Therapeutics, Inc.

FAQ

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What will Viking Therapeutics' SUNRISE Phase 3 trials measure for oral VK2735?

Both trials will measure percent change in body weight from baseline versus placebo after 68 weeks as their primary endpoint. Each targets enrollment of 560 adults, with SUNRISE-1 studying adults without type 2 diabetes and SUNRISE-2 studying adults with type 2 diabetes.

What oral VK2735 doses will Viking Therapeutics test in the SUNRISE trials?

Participants in both SUNRISE trials will be randomly assigned to once-daily oral VK2735 at 27.5 mg, 35 mg, 55 mg, or placebo. The studies are randomized, double-blind and multicenter. Additional endpoints include the percentage of patients achieving at least 5%, 10%, 15% or 20% body weight reduction from baseline.

Who is eligible for Viking Therapeutics' SUNRISE-1 oral VK2735 trial?

SUNRISE-1 will include adults without type 2 diabetes who are obese, with BMI ≥30 kg/m2, or overweight, with BMI ≥27 kg/m2, and have at least one weight-related comorbidity. SUNRISE-2 will enroll obese or overweight adults with type 2 diabetes.

What dosing correction did Viking Therapeutics make for its VK2735 maintenance trial?

The maintenance trial will evaluate daily oral doses, monthly subcutaneous doses, every-other-week subcutaneous doses, or placebo, rather than weekly oral doses. This corrects the dosing description in Viking's October 6, 2026 announcement. Subcutaneous dosing means an injection under the skin.