VK2735 for Obesity

(VENTURE Trial)

No longer recruiting at 19 trial locations

Overseen By Stephanie Herman

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Viking Therapeutics, Inc.

Must not be taking: GLP-1 agonists, Weight loss meds

Disqualifiers: Diabetes, Chronic pancreatitis, others

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

Compensation: Varies

Number of Visits: 13

Duration: 13 weeks

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 promoting weight loss in individuals who are obese or overweight. The research aims to assess the safety and efficacy of VK2735 compared to a placebo (a substance with no active drug). Participants will receive either VK2735 or a placebo once a week. This trial may suit adults with a BMI of 30 or higher, or 27 or higher if they have other related health issues. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

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

The trial requires that you have not used any GLP-1 receptor agonists, GLP-1/GIP dual agonists, or any weight loss medications in the 6 months before screening. Other medications are not specifically mentioned, 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 has shown that VK2735 was tested in earlier studies and found to be safe and well-tolerated. Participants in these studies did not report any serious side effects, indicating that most people handled the treatment well. VK2735 targets two different parts of the body that help control appetite and weight. Overall, evidence suggests VK2735 is a promising option for those considering joining a clinical trial for weight management. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for obesity?

Researchers are excited about VK2735 for obesity because it works as a dual agonist of GLP-1 and GIP peptides, which is a different mechanism compared to many current treatments. While standard therapies often focus on just GLP-1 pathways, VK2735 also targets GIP, potentially enhancing weight loss effects. This dual action could offer more significant benefits in appetite regulation and metabolic control, making it a promising option for those who haven't achieved their desired results with existing medications.

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

Research has shown that VK2735, which participants in this trial may receive, may aid weight loss in people with obesity. In earlier studies, 97% of those taking VK2735 lost at least 5% of their body weight, compared to only 10% of those on a placebo. On average, participants lost up to 12.2% of their starting weight after 13 weeks. Specifically, VK2735 led to about 10.9% more weight loss than the placebo. The treatment affects hormones that regulate appetite and metabolism. These results suggest VK2735 could be a helpful option for weight management in adults with obesity. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with obesity (BMI ≥30) or overweight (BMI ≥27) with a weight-related condition, but not heavier than a BMI of 50. It's not for those who've had significant weight changes recently, have diabetes or chronic pancreatitis, used certain drugs for weight loss in the past 6 months, or have specific medical conditions that could affect their participation.

Inclusion Criteria

My BMI is between 27 and 50, and I may have a weight-related health issue.

Exclusion Criteria

Calcitonin ≥20 ng/L measured by central laboratory at screening (individuals with elevated calcitonin at initial screening may be re-screened)

I have been diagnosed with chronic pancreatitis.

I haven't taken any GLP-1 receptor agonists 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

13 weeks

13 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• VK2735

Trial Overview

The study tests VK2735 against a placebo to see if it's safe and effective for weight loss. Participants will be randomly assigned to receive either VK2735 or a placebo once weekly for 13 weeks while researchers track safety, how well it works, and how the body processes the drug.

How Is the Trial Designed?

Group I: VK2735 (Dose #4) Experimental Treatment 1 Intervention

VK2735 is a peptide GLP-1 and GIP dual agonist

Group II: VK2735 (Dose #3) Experimental Treatment 1 Intervention

VK2735 is a peptide GLP-1 and GIP dual agonist

Group III: VK2735 (Dose #2) Experimental Treatment 1 Intervention

VK2735 is a peptide GLP-1 and GIP dual agonist

Group IV: VK2735 (Dose #1) Experimental Treatment 1 Intervention

VK2735 is a peptide GLP-1 and GIP dual agonist

Group V: VK2735 (Placebo) Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Viking Therapeutics, Inc.

Lead Sponsor

Trials

7

Recruited

990+

Published Research Related to This Trial

Currently, there are three FDA-approved medications for obesity: phentermine and sibutramine, which suppress appetite, and orlistat, which blocks fat absorption, highlighting the evolving landscape of pharmacological treatments for obesity.

Over 150 new weight loss agents are in development, suggesting that future obesity treatments may involve combinations of therapies targeting different physiological mechanisms to enhance efficacy and overcome the body's natural resistance to weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological therapies for obesity. Kaplan, LM.[2007]

Four new obesity drug therapies approved by the FDA since 2012—lorcaserin, phentermine/topiramate, naltrexone/bupropion, and liraglutide 3.0 mg—can lead to weight loss of about 3 to 9% beyond lifestyle changes after one year.

The effectiveness of these drugs varies among individuals, highlighting the importance of personalized treatment plans that consider the benefits and risks for each patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of Obesity: Clinical Trials to Clinical Practice. Gadde, KM., Pritham Raj, Y.[2018]

The combination of phentermine and topiramate is currently the most effective FDA-approved treatment for obesity, followed by lorcaserin and bupropion/naltrexone.

Effective obesity management should consider not only medication efficacy but also comorbidities, drug interactions, and personalized treatment approaches based on individual genetic profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Precision Obesity Treatments Including Pharmacogenetic and Nutrigenetic Approaches. Solas, M., Milagro, FI., Martínez-Urbistondo, D., et al.[2018]

Citations

1.

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 ...

2.

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 ...

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.

ir.vikingtherapeutics.com

ir.vikingtherapeutics.com/2025-10-22-Viking-Therapeutics-Reports-Third-Quarter-2025-Financial-Results-and-Provides-Corporate-Update

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 ...

5.

biospace.com

biospace.com/drug-development/viking-crashes-as-obesity-pill-delivers-over-12-weight-loss

Viking Crashes as Obesity Pill Delivers Over 12% Weight ...

On a placebo-corrected basis, VK2735 lowered body weight by as high as 10.9% at 13 weeks. Likewise, 80% of patients hit at least 10% weight loss ...

6.

ir.vikingtherapeutics.com

ir.vikingtherapeutics.com/2025-10-29-Viking-Therapeutics-to-Highlight-Clinical-Data-from-VK2735-Obesity-Program-in-Presentations-at-ObesityWeek-R-2025

News & Events

Activation of the glucagon-like peptide 1 (GLP-1) receptor has been shown to decrease glucose, reduce appetite, lower body weight, and improve ...

7.

vikingtherapeutics.com

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

VK2735

During the first quarter of 2023, the company announced results from this study, which demonstrated that treatment with VK2735 was safe and well-tolerated when ...

8.

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 ...

9.

prnewswire.com

prnewswire.com/news-releases/viking-therapeutics-to-highlight-clinical-data-from-vk2735-obesity-program-in-presentations-at-obesityweek-2025-302597590.html

Viking Therapeutics to Highlight Clinical Data from VK2735 ...

One ObesityWeek presentation will report results of an exploratory analysis from the company's Phase 2 VENTURE clinical trial, which evaluated ...

10.

ddw-online.com

ddw-online.com/mixed-top-line-results-for-vikings-oral-obesity-drug-36097-202508/

Mixed top-line results for Viking's oral obesity drug

Top-line study results show that participants receiving VK2735 demonstrated reductions in mean body weight after 13 weeks ranging up to 12.2% ...