VK2735 for Weight Loss

(VANQUISH 1 Trial)

Not currently recruiting at 137 trial locations

Overseen By Hannah Contreras

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Viking Therapeutics, Inc.

Must not be taking: Glucose-lowering agents

Disqualifiers: Diabetes, Thyroid carcinoma, Pancreatitis, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, VK2735 (an experimental drug), to evaluate its effectiveness in aiding weight loss. The goal is to determine whether individuals who are obese or overweight can safely lose weight with this treatment. The trial includes three different doses and a placebo group for comparison. Individuals with a BMI of 30 or more, or a BMI of 27 or more with a weight-related condition such as high blood pressure or sleep apnea, may qualify to participate. 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 weight loss treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on glucose-lowering medications, you must stop them at least 90 days before screening.

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

Research has shown that VK2735 has been safe in earlier studies. In one study, after 13 weeks of taking VK2735 once a week, most participants did not experience serious side effects, indicating the treatment was generally safe. Another study also reported positive results regarding its safety and tolerability.

While these findings are encouraging, VK2735 is still under investigation to confirm its long-term safety and effectiveness in a larger population. This ongoing research will help ensure the treatment is safe and effective for those considering participation in this clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for weight loss?

Researchers are excited about VK2735 for weight loss because it offers a novel approach compared to existing treatments. Unlike most weight loss medications that primarily focus on appetite suppression or fat absorption, VK2735 operates through a different mechanism by targeting specific metabolic pathways to potentially enhance energy expenditure and fat burning. Moreover, VK2735 is administered once weekly, which could improve adherence compared to daily medications. This combination of a unique mechanism and convenient dosing schedule makes VK2735 a promising candidate in the fight against obesity.

What evidence suggests that VK2735 might be an effective treatment for weight loss?

Research has shown that VK2735 is promising for weight loss. Up to 88% of participants taking VK2735 lost at least 10% of their body weight, compared to only 4% of those on a placebo. Some participants lost as much as 12.2% of their starting weight. The treatment also improved heart health and metabolism. Overall, VK2735 has demonstrated encouraging results in aiding weight loss. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for adults who are obese (BMI ≥30) or overweight (BMI ≥27) with at least one weight-related health issue, but not Type 2 Diabetes. Participants should be committed to a long-term study lasting over a year.

Inclusion Criteria

BMI calculated at the Screening visit will be used to determine eligibility

My BMI is 30 or higher, or it's 27 or higher with a weight-related health issue.

I am 18 years old or older.

Exclusion Criteria

I or my family have a history of MTC or MEN2.

I have a history of pancreatitis.

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

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

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 VK2735's ability to manage weight is being tested in this phase 3 trial. It's compared against a placebo over 78 weeks, with participants' weight loss and the drug’s safety and effects on the body closely monitored.

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. 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 VENTURE Study Exploratory Analysis Shows VK2735 Improved Cardiometabolic Parameters After 13 Weeks; Reducing Prediabetes and Metabolic ...

2. 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 ...

3. 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% ... Once-daily oral VK2735 produced statistically significant mean body weight reductions of up to 12.2% from baseline at 13 weeks.

4. 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 ...

5. 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 ...