VK2735 for Weight Loss in Type 2 Diabetes

Recruiting at 130 trial locations

Overseen By Maris Johnson

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Viking Therapeutics, Inc.

Must be taking: Oral glycemic-lowering

Must not be taking: Amylin analogues, DPP-4 inhibitors

Disqualifiers: Type 1 diabetes, Severe hypoglycemia, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 78 weeks

1100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called VK2735 to determine its effectiveness in helping people with Type 2 Diabetes lose weight. Participants will receive either varying doses of VK2735 or a placebo (a substance with no active drug) to compare outcomes. The study aims to assess the effectiveness and safety of VK2735 for weight loss. It seeks adults with Type 2 Diabetes who are overweight or obese and have stable diabetes management. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment.

Do I have to stop taking my current medications for the trial?

You can continue taking your current diabetes medications, except for amylin analogues, DPP-4 inhibitors, GLP-1R agonists, or dual GLP-1/GIP receptor agonists. The trial does not specify if you need to stop other medications, so it's best to discuss with the trial team.

Is there any evidence suggesting that VK2735 is likely to be safe for humans?

Research shows that VK2735 is generally safe and well-tolerated. In an earlier study, participants took VK2735 once a week for 13 weeks, and most did not experience serious side effects.

While safety data from the current Phase 3 trial is not yet available, VK2735's progression to this stage suggests that earlier studies did not identify major safety issues. Phase 3 trials typically involve more participants to confirm a treatment's safety and efficacy. If VK2735 had serious safety problems, it likely would not have advanced to this phase.

Overall, VK2735 appears well-tolerated, but ongoing and future studies must continue to monitor participant responses. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Type 2 Diabetes?

Researchers are excited about VK2735 for weight loss in type 2 diabetes because it offers a novel approach compared to existing treatments. Unlike traditional therapies like metformin or GLP-1 receptor agonists, VK2735 is administered as a once-weekly injection with varying doses, which may lead to improved patient compliance. This treatment works by targeting specific pathways in the body differently, potentially enhancing weight loss and glucose control more effectively. Additionally, the flexibility in dosing could provide a more tailored approach to individual patient needs, making it a promising option in managing type 2 diabetes.

What evidence suggests that VK2735 might be an effective treatment for weight loss in Type 2 Diabetes?

Research has shown that VK2735 holds promise for weight loss in people with Type 2 Diabetes. Recent studies found that up to 97% of those taking VK2735 lost at least 5% of their body weight. Additionally, up to 88% of participants lost 10% or more, a significant improvement compared to just 4% in the placebo group (a pill with no active ingredient). In this trial, participants will receive different doses of VK2735 or a placebo to further evaluate its effectiveness. These results suggest that VK2735 could be an effective option for managing weight in individuals with obesity and diabetes. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with Type 2 Diabetes who are overweight or obese. Specific eligibility details aren't provided, but typically participants must meet certain health criteria and not be taking conflicting medications.

Inclusion Criteria

I have Type 2 Diabetes with an HbA1c level between 7% and 11%, and my treatment has been stable for the last 3 months.

I am 18 years old or older.

Body mass index (BMI) ≥27 kg/m2

Exclusion Criteria

I have had two high blood sugar readings above 270 mg/dL recently.

I have had or am planning to have a special procedure for weight loss or had a weight loss device removed in the last 6 months.

I have Type 1 diabetes or a history of severe diabetes complications, but not Type 2 diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VK2735 or placebo once weekly for weight management over 78 weeks

78 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VK2735

Trial Overview

The study tests VK2735's ability to manage weight in the context of Type 2 Diabetes. It's a phase 3 trial comparing VK2735 against a placebo over 78 weeks, with patients randomly assigned to either group in a double-blind manner.

How Is the Trial Designed?

Group I: Active Assignment (Dose #3) Experimental Treatment 1 Intervention

VK2735 17.5mg Once Weekly

Group II: Active Assignment (Dose #2) Experimental Treatment 1 Intervention

VK2735 12.5mg Once Weekly

Group III: Active Assignment (Dose #1) Experimental Treatment 1 Intervention

VK2735 7.5mg Once Weekly

Group IV: Placebo Assignment Placebo Group 1 Intervention

VK2735 Placebo Comparator Once Weekly

Who Is Running the Clinical Trial?

Viking Therapeutics, Inc.

Lead Sponsor

Trials

7

Recruited

990+

Citations

1.

vikingtherapeutics.com

vikingtherapeutics.com/pipeline/metabolic-disease-program/vk2735/

VK2735

Up to 88% of patients in VK2735 treatment groups achieved ≥10% weight loss, compared with 4% for placebo. VK2735 demonstrated encouraging safety and ...

2.

appliedclinicaltrialsonline.com

appliedclinicaltrialsonline.com/view/oral-glp-1-gip-dual-agonist-vk2735-achieves-weight-loss-venture-trial

Oral GLP-1/GIP Dual Agonist VK2735 Achieves Up to 12% ...

VK2735 achieved significant weight reduction, with up to 12.2% mean body weight loss from baseline over 13 weeks. The trial's exploratory cohort ...

3.

ir.vikingtherapeutics.com

ir.vikingtherapeutics.com/2025-08-19-Viking-Therapeutics-Announces-Positive-Top-Line-Results-from-Phase-2-VENTURE-Oral-Dosing-Trial-of-VK2735-Tablet-Formulation-in-Patients-with-Obesity

News & Events

Up to 97% of subjects in the VK2735 treatment groups achieved ≥5% weight loss, compared with 10% for placebo, and up to 80% of subjects in ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07104500

NCT07104500 | VK2735 for Weight Management Phase 3

This is a phase 3, multicenter, 78-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the weight loss efficacy as well ...

5.

prnewswire.com

prnewswire.com/news-releases/viking-therapeutics-announces-positive-top-line-results-from-phase-2-venture-oral-dosing-trial-of-vk2735-tablet-formulation-in-patients-with-obesity-302533355.html

Viking Therapeutics Announces Positive Top-Line Results ...

Up to 97% of subjects in the VK2735 treatment groups achieved ≥5% weight loss, compared with 10% for placebo, and up to 80% of subjects in ...

6.

ahajournals.org

ahajournals.org/doi/10.1161/circ.152.suppl_3.4367152

Abstract 4367152: VANQUISH-2: Phase 3, Randomized ...

Conclusions: VANQUISH-2 will provide the first Phase 3 efficacy and safety data, including CM parameters, of the dual GIP/GLP-1 receptor agonist ...

7.

ir.vikingtherapeutics.com

ir.vikingtherapeutics.com/2025-11-06-Viking-Therapeutics-Highlights-Clinical-Data-from-VK2735-Obesity-Program-in-Presentation-at-ObesityWeek-R-2025

News & Events

Data from the study showed that 78% of VK2735-treated patients who were characterized as prediabetic at baseline had successfully shifted to ...

8.

prnewswire.com

prnewswire.com/news-releases/viking-therapeutics-highlights-clinical-data-from-vk2735-obesity-program-in-presentation-at-obesityweek-2025-302606589.html

Viking Therapeutics Highlights Clinical Data from VK2735 ...

In addition, up to 88% of patients in VK2735 treatment groups achieved ≥10% weight loss, compared with 4% for placebo. Additionally, as ...