The Overview
Viking Therapeutics has initiated Part 2 of an exploratory clinical trial for its dual GLP-1/GIP receptor agonist, VK2735, in patients with obesity. This randomized, double-blind, placebo-controlled study, involving approximately 195 adults, aims to evaluate various oral and subcutaneous maintenance dosing regimens (daily oral, weekly oral, monthly subcutaneous, every-other-week subcutaneous) to sustain weight loss achieved with initial weekly subcutaneous VK2735. The trial will assess safety, tolerability, pharmacokinetics, and changes in body weight, with results expected in 2027.
Knolens Analysis
At a Glance
| Indication | Obesity |
| Drug | VK2735 |
| Mechanism of Action | GLP-1 and GIP receptor dual agonist |
| Company | Viking Therapeutics, Inc. |
| Category | Clinical Trial Event |
| Sub Category | Trial Initiation / First Patient In (FPI) |
| Therapeutic Area | Endocrinology & Metabolic Diseases |
| Study Design | Randomized, double-blind, placebo-controlled |
| Maintenance Study Patient Population | Approximately 195 adults with obesity (BMI ≥30 kg/m2) who are otherwise healthy |
| Initial Dosing Phase | Weekly subcutaneous VK2735 or placebo for 21 weeks |
| Maintenance Dosing Regimens | Daily oral doses, weekly oral doses, monthly subcutaneous doses, every-other-week subcutaneous doses, or placebo |
| Exploratory Endpoints | Safety, tolerability, pharmacokinetic profile, changes in body weight from baseline and Week 21 to Week 33 |
| Results Anticipated | 2027 |
| Ongoing Phase 3 Trials | VANQUISH-1, VANQUISH-2 |
| VANQUISH-1 Patient Enrollment | Approximately 4,500 adults with obesity (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition, no type 2 diabetes |
| VANQUISH-2 Patient Enrollment | Approximately 1,000 adults with type 2 diabetes who have obesity or are overweight |
| VANQUISH Trials Dosing | VK2735 7.5 mg, 12.5 mg, 17.5 mg, and placebo weekly for 78 weeks |
Viking Initiates Oral Maintenance Dosing Study for VK2735 in Obesity
Viking Therapeutics has initiated Part 2 of an exploratory clinical trial for its dual GLP-1/GIP receptor agonist, VK2735, in patients with obesity. This randomized, double-blind, placebo-controlled study, involving approximately 195 adults, aims to evaluate various oral and subcutaneous maintenance dosing regimens (daily oral, weekly oral, monthly subcutaneous, every-other-week subcutaneous) to sustain weight loss achieved with initial weekly subcutaneous VK2735. The trial will assess safety, tolerability, pharmacokinetics, and changes in body weight, with results expected in 2027.
- Part 2 of the maintenance study will explore a range of VK2735 dosing options, including daily and weekly oral tablets, as well as monthly and every-other-week subcutaneous injections, alongside placebo. The primary objectives are to evaluate the safety, tolerability, and pharmacokinetic profile of these regimens, with exploratory endpoints assessing body weight changes from baseline and Week 21 to Week 33.
- This initiation follows positive top-line results from Part 1 of the maintenance study, which evaluated subcutaneous dosing regimens. Viking aims to provide greater optionality and flexibility in long-term weight management, believing that diverse dosing options, both oral and subcutaneous, are crucial for improving patient adherence and achieving personalized weight loss goals.
- In addition to the maintenance study, Viking is conducting two fully enrolled Phase 3 trials, VANQUISH-1 and VANQUISH-2, evaluating weekly subcutaneous VK2735 for 78 weeks. VANQUISH-1 includes approximately 4,500 adults with obesity or overweight without type 2 diabetes, while VANQUISH-2 enrolls about 1,000 adults with type 2 diabetes who are obese or overweight, testing 7.5 mg, 12.5 mg, 17.5 mg, and placebo doses.
Frequently Asked Questions
Which GLP-1 is strongest for weight loss?
Tirzepatide, a dual GIP and GLP-1 receptor agonist, has demonstrated the greatest weight loss efficacy among currently approved incretin-based therapies. Clinical trials show it achieves superior weight reduction compared to semaglutide and other GLP-1 receptor agonists, with average weight loss exceeding 20% in some studies.
Is VK2735 a peptide?
VK2735 is a novel, investigational dual agonist of the glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. It is a peptide-based therapeutic candidate developed by Viking Therapeutics. This compound is designed to leverage the metabolic benefits of both incretin pathways, similar to other peptide-based GLP-1/GIP agonists in development or on the market.
What new weight loss drugs are coming in 2026?
Several highly anticipated weight loss drugs are expected to be nearing or achieving market entry by 2026. Key candidates include Eli Lilly's retatrutide, a GLP-1/GIP/glucagon receptor agonist, and Novo Nordisk's cagrisema, a co-formulation of semaglutide and cagrilintide. Additionally, high-dose oral semaglutide from Novo Nordisk and Boehringer Ingelheim/Zealand Pharma's survodutide (a GLP-1/glucagon dual agonist) are also in late-stage development with potential for launch around that timeframe.
What is the latest news on Viking Therapeutics?
Viking Therapeutics recently announced positive Phase 1 data for its oral GLP-1/GIP dual agonist, VK2735, demonstrating dose-dependent weight loss and good tolerability. This follows strong Phase 2 VENTURE trial results for the injectable formulation of VK2735, which showed significant weight reduction in obese and overweight adults. The company is now advancing both formulations, positioning VK2735 as a potential competitor in the rapidly growing obesity market.
What is the newest weight-loss drug currently in trials?
Eli Lilly's retatrutide, a GLP-1, GIP, and glucagon receptor triple agonist, is currently in Phase 3 trials for weight management and obesity. Early data from Phase 2 have demonstrated significant weight loss, positioning it as a potential next-generation therapy beyond existing dual agonists. Another prominent investigational drug in Phase 3 is Eli Lilly's orforglipron, an oral non-peptide GLP-1 receptor agonist. Novo Nordisk's CagriSema, a co-formulation of cagrilintide and semaglutide, is also in late-stage development.
What state is #1 in obesity?
West Virginia consistently ranks as the state with the highest adult obesity prevalence in the United States. Recent data, including the CDC's 2022 Behavioral Risk Factor Surveillance System (BRFSS), indicates its adult obesity rate exceeds 44%. This persistent ranking underscores significant public health challenges and the need for targeted interventions in chronic disease prevention and management within the state.
What is the most successful treatment for obesity?
The most successful pharmacological treatments for obesity are GLP-1 receptor agonists, with semaglutide and tirzepatide demonstrating the highest efficacy in achieving significant and sustained weight loss in clinical trials. These agents have shown superior weight reduction compared to other approved anti-obesity medications. However, bariatric and metabolic surgery generally achieves the greatest and most durable weight loss, offering superior outcomes for many patients but involving an invasive procedure with associated risks.
When will retatrutide be available?
Retatrutide is currently in Phase 3 clinical development and has not yet received regulatory approval from agencies like the FDA or EMA. Consequently, it is not commercially available. Its future availability is contingent upon successful trial completion and subsequent marketing authorization.
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