Viking Therapeutics Launches Phase 3 Study for VK2735 in Obesity Treatment

Viking Therapeutics, Inc., a forward-thinking biopharmaceutical firm, has officially initiated the SUNRISE Phase 3 clinical program for its promising oral treatment, VK2735. This dual receptor agonist, which targets both glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors, aims to address the pressing issue of obesity and its related metabolic disorders.

Overview of the SUNRISE Phase 3 Program

The SUNRISE program encompasses two pivotal studies: SUNRISE-1 and SUNRISE-2. These randomized, double-blind, placebo-controlled trials will evaluate the effects of VK2735 on obese adults, both with and without type 2 diabetes. Each study will involve 560 participants, who will receive either VK2735 in one of several dosage amounts—27.5 mg, 35 mg, or 55 mg—or a placebo, for a duration of 68 weeks.

The primary goal of these studies is to assess the percentage change in body weight from the beginning of the trials, comparing those on VK2735 to those on placebo. Secondary objectives will further evaluate various safety and efficacy measures, including the proportion of patients achieving significant weight loss defined as 5%, 10%, 15%, or 20% reductions from their starting weight.

Significance of VK2735

Dr. Brian Lian, the CEO of Viking, expressed excitement about this new phase, emphasizing the potential of VK2735 as a convenient oral option that might enhance adherence to treatment protocols for obesity. He noted that while obesity is a chronic condition requiring long-term management, VK2735 may serve as either an initiation therapy or part of a maintenance regimen. This flexibility could play a crucial role in expanding treatment options for both patients and healthcare providers.

VK2735 is notable for being the first oral dual GLP-1/GIP agonist undergoing clinical trials, making it a significant advancement in the treatment landscape for obesity. Previous phase 2 studies have shown promise, highlighting VK2735's ability to produce clinically meaningful weight loss in participants, thus positioning it favorably within a competitive market.

Prior Studies and Safety

In 2025, Viking released positive findings from the VENTURE-Oral Dosing Study concerning the oral formulation of VK2735. Results indicated that participants experienced remarkable weight loss, with as much as 12.2% reduction after just 13 weeks of once-daily dosing. These results demonstrate a strong dose-dependent effect, with significant weight loss noted across all dosage levels beyond 15 mg, starting from the first week and persisting throughout the study.

Safety profiles from earlier trials showed that the majority of reported adverse events were mild to moderate, particularly gastrointestinal issues, which are common with GLP-1/GIP receptor agonists. Importantly, these GI-related side effects typically subsided with continued use, suggesting a manageable safety profile.

Future Developments

Alongside the SUNRISE program, Viking is also conducting maintenance trials for VK2735, which aim to fine-tune dosing strategies for effective long-term weight management. The company is advancing its pipeline, particularly with VANQUISH-1 and VANQUISH-2, two additional Phase 3 studies focusing on a subcutaneous formulation of VK2735. These studies are designed to assess VK2735's effect among individuals with obesity or type 2 diabetes, further reinforcing Viking's commitment to innovative obesity therapeutics.

Conclusion

VK2735's entry into Phase 3 clinical trials marks a new chapter in the fight against obesity. As Viking Therapeutics continues to explore various formulations and dosing strategies, the medical community eyes these advances with hope for improved treatment options for those struggling with weight-related challenges. As the trials progress, Viking's innovative approach exemplifies the potential for new methods to address a growing global health crisis. For more updates on VK2735 and Viking's other initiatives, visit Viking Therapeutics.