VK2735 for Obesity

No longer recruiting at 15 trial locations
BS
SH
Overseen ByStephanie Herman
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Viking Therapeutics, Inc.
Prior Safety DataThis treatment has passed at least one previous human trial

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 safety and effectiveness in weight loss. VK2735 is a daily pill that targets specific hormones to control hunger and manage weight. The trial compares various doses of VK2735 against a placebo (a look-alike pill with no active ingredient) to identify the most effective dose. Suitable participants are adults with a BMI over 30, or a BMI over 27 with an additional weight-related health issue such as high blood pressure or sleep apnea. As a Phase 2 trial, this research measures VK2735's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in weight-loss treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used any GLP-1 receptor agonists or weight loss medications within 6 months before the screening.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that VK2735, a new treatment under study, has promising safety results. In one study, participants received VK2735 as a weekly injection under the skin, and it was generally well-tolerated, with no major safety issues. Another study found that when VK2735 was administered as a pill over 13 weeks, most participants tolerated it well, although some experienced mild to moderate side effects, which are common with similar treatments.

A similar drug, tirzepatide, which functions like VK2735, has already received FDA approval for other uses. This adds some confidence about its safety, but it's important to remember that treatments can affect people differently.

In summary, while some mild side effects might occur, evidence suggests VK2735 is generally safe. It's always important to consult a healthcare provider about any concerns before joining a trial.12345

Why are researchers excited about this trial's treatment?

Researchers are excited about VK2735 for obesity because it is a peptide that acts as a dual agonist for GLP-1 and GIP receptors. Most current treatments for obesity, like medications targeting GLP-1 alone, focus on appetite suppression and delayed gastric emptying. However, VK2735 targets both GLP-1 and GIP receptors, potentially enhancing its ability to regulate glucose and fat metabolism, leading to more effective weight loss. This dual action may offer a new approach for individuals who have not achieved desired results with existing therapies. By combining these mechanisms, VK2735 aims to provide a more comprehensive solution to obesity management.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that VK2735, a new treatment under study in this trial, aids in weight loss. In an earlier study, participants lost an average of 12.2% of their body weight over 13 weeks. This treatment boosts the body's natural hormones that regulate hunger and energy use. The results are encouraging and suggest that VK2735 could effectively promote weight loss in individuals who are overweight or obese. This trial includes various treatment arms to confirm its benefits at different dosages.12467

Are You a Good Fit for This Trial?

This trial is for adults who are obese with a BMI of 30 or higher, or overweight with a BMI of at least 27 and have one weight-related health issue. Key eligibility details aren't provided, so interested individuals should inquire further about specific inclusion and exclusion criteria.

Inclusion Criteria

My BMI is between 27 and 50, and I may have a condition like high blood pressure or sleep apnea.

Exclusion Criteria

I have been diagnosed with diabetes.
I have been diagnosed with chronic pancreatitis.
I haven't taken any GLP-1 drugs in the last 6 months.
See 4 more

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 daily for weight management over 13 weeks

13 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 against a placebo to see if it helps with weight loss. Participants will be randomly assigned to receive either the drug or placebo once daily for 13 weeks in this double-blind study where neither they nor the researchers know who gets what.
How Is the Trial Designed?
7Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Assignment (Dose #6)Experimental Treatment1 Intervention
Group II: Active Assignment (Dose #5)Experimental Treatment1 Intervention
Group III: Active Assignment (Dose #4)Experimental Treatment1 Intervention
Group IV: Active Assignment (Dose #3)Experimental Treatment1 Intervention
Group V: Active Assignment (Dose #2)Experimental Treatment1 Intervention
Group VI: Active Assignment (Dose #1)Experimental Treatment1 Intervention
Group VII: Placebo AssignmentPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Viking Therapeutics, Inc.

Lead Sponsor

Trials
7
Recruited
990+

Citations

VK2735A study intended to evaluate the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK2735, administered subcutaneously, once weekly.
Oral GLP-1/GIP Dual Agonist VK2735 Achieves Up to 12% ...The Phase II VENTURE-Oral Dosing trial of VK2735 met primary and secondary endpoints, showing up to 12.2% mean weight loss at 13 weeks with ...
NCT07104500 | VK2735 for Weight Management Phase 3This is a phase 3, multicenter, 78-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the weight loss efficacy as well ...
Mixed top-line results for Viking's oral obesity drugViking Therapeutics has released positive top-line results from its Phase II clinical trial of the oral tablet formulation of VK2735.
Viking Therapeutics Announces Initiation of Phase 3 ...The VANQUISH Phase 3 program includes two studies evaluating VK2735: one in adults with obesity and one in obese or overweight adults with type 2 diabetes.
Viking Therapeutics Highlights Clinical Data from VK2735 ...VENTURE Study Exploratory Analysis Shows VK2735 Improved Cardiometabolic Parameters After 13 Weeks; Reducing Prediabetes and Metabolic ...
Viking Therapeutics Announces Initiation of VK2735 ...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 ...
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