VK2735 for Obesity

(VENTURE Trial)

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

176 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a treatment called VK2735 to help adults who are overweight or obese lose weight. The study focuses on people who also have other health issues related to their weight. Researchers want to see if VK2735 is safe and effective for weight loss.

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.

How does the drug VK2735 for obesity differ from other drugs?

VK2735 is a novel treatment for obesity that may offer a different mechanism of action compared to existing drugs like orlistat, lorcaserin, and liraglutide, which target fat absorption, appetite suppression, and hormone regulation. While specific details about VK2735's unique features are not provided, it is part of ongoing research to explore new molecular targets for obesity treatment. ^{1 2 3 4 5}

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

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Precision Obesity Treatments Including Pharmacogenetic and Nutrigenetic Approaches. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Pharmacotherapy in obesity: a systematic review and meta-analysis of randomized controlled trials of anti-obesity drugs. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for obesity. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Pharmacological therapies for obesity. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of Obesity: Clinical Trials to Clinical Practice. [2018]