At the 2025 American Heart Association (AHA) Scientific Sessions held in New Orleans, Louisiana, from 7 to 10 November 2025, research plans for a Phase III multicentre, randomised trial of VK2735 were presented. The study seeks to evaluate the weight loss efficacy, safety, tolerability, pharmacodynamics and pharmacokinetic effects of VK2735 in obese or overweight adults with type 2 diabetes (T2D).
Diabetes is a chronic condition resulting from the inability of the body to regulate blood sugar levels due to problems with the hormone insulin, which facilitates the uptake and use of blood glucose for energy. T2D is the most common form, accounting for 95% of cases. It is characterised by increased resistance to insulin or the body not producing enough, leading to abnormally high blood glucose levels which can increase the risk of obesity, kidney failure and cardiovascular disease (CVD). CVD is a leading cause of death in diabetes, and obesity treatment has become an important strategy for the prevention and management of T2D.
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Novel long-acting incretin mimetics such as VK2735 function as dual agonists of glucagon-like peptide 1 (GLP-1) receptors and glucose-dependent insulinotropic polypeptide, which offers glycaemic control, reduced cardiometabolic risks and body weight reductions. A Phase II trial of VK2735 reportedly demonstrated significant weight loss reduction in overweight/obese participants.
The VANQUISH-2 Phase III trial seeks to further evaluate VK2735’s efficacy by recruiting participants from US sites and randomly administering a weekly subcutaneous injection of placebo or VK2735 at doses of 7.5mg, 12.5mg or 17.5mg. The primary endpoint is percentage change in body weight from baseline, while secondary endpoints include weight loss reductions (≥5%, ≥10%, ≥15%, and ≥20%). Other additional outcomes to be assessed include functional mobility, cardiovascular and metabolic health, mental health and work productivity.
If successful in the Phase III trial, VK2735 would enter direct competition with established dual agonists such as Eli Lilly’s tirzepatide (Mounjaro/Zepbound) and similar agents in Phase III such as Roche’s CT-388 and Gan & Lee Pharmaceuticals’ bofanglutide. If the Phase III data matches or surpasses the efficacy of tirzepatide in the 15% to 20% range and shows good metabolic improvement, it could capture a major market share. However, other Phase III candidates such as bofanglutide and Eli Lilly’s orforglipron may pose major competition due to biweekly dosing and oral formulation, respectively. These offer a clear advantage of convenience and possibly improved patient compliance, which can win market share. Nonetheless, the cost of therapy, regulatory approval and individual weight loss efficacy are all variables that would determine market uptake for many pipeline drugs.
A key opinion leader (KOL) interviewed by GlobalData noted: “It’s not very interesting to know if a drug is able to produce percent weight loss of 20% instead of 25%. This is not a real problem. The problem would be: what are the health outcome of this weight loss in the long term? What we need is trials much more focused on outcomes beyond weight loss, and longer trials too.” As such, the assessment of VK2735’s effects beyond weight loss, especially its potential impact on mental health and productivity, is crucial, as these broader outcomes could significantly improve its clinical and commercial value.
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By GlobalDataLooking ahead, the existence of VK2735 in the obesity space and its success could offer strong competition as its early trial data reinforces the superior potency of hitting multiple hormonal pathways for both weight loss and cardiometabolic outcomes. This could potentially accelerate innovation, pushing companies with approved single agonists (semaglutide, liraglutide) and combination therapy (tirzepatide) towards developing oral, longer-acting versions with improved efficacy, reduced side effects and sustained weight loss. Success for VK2735 may also prompt earlier, larger investments and faster clinical projection in quadruple therapies for companies to stay ahead of the rapidly evolving obesity therapy space.
