VK2735 for weight management in adults
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, 13-week Dose Finding Study of VK2735 Oral Formulation for Weight Management in Subjects Who Are Obese, or Overweight With at Least One Weight-related Comorbid Condition
PHASE2 · Viking Therapeutics, Inc. · NCT06828055
This study is testing a new oral medication called VK2735 to see if it can help adults who are overweight or obese lose weight and improve their health over 13 weeks.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Viking Therapeutics, Inc. (industry) |
| Locations | 15 sites (Peoria, Arizona and 14 other locations) |
| Trial ID | NCT06828055 on ClinicalTrials.gov |
What this trial studies
This phase 2 clinical trial is a 13-week randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and weight loss efficacy of VK2735, an oral formulation, in adults who are obese or overweight with at least one weight-related co-morbid condition. Participants will receive either VK2735 or a matched placebo once daily. The study aims to assess pharmacodynamic effects and pharmacokinetics alongside weight loss outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a BMI of 27 kg/m2 or higher and at least one weight-related co-morbid condition.
Not a fit: Patients with a history of diabetes mellitus or chronic pancreatitis, or those with significant medical or psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide an effective new option for weight management in adults struggling with obesity or overweight conditions.
How similar studies have performed: Other studies have shown promise in weight management approaches, but the specific formulation VK2735 is novel and has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years of age at the time of signing the informed consent. 2. Body mass index (BMI) ≥30 kg/m2 OR ≥27 kg/m2 with at least one weight-related co-morbid condition (treated or untreated), and BMI \<50 kg/m2 * Weight-related co-morbid conditions include hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease. * BMI calculated at the Screening visit will be used to determine eligibility. Exclusion Criteria: 1. History of or current clinically significant medical or psychiatric disorder that, in the opinion of the Investigator, does not support study participation 2. Self-reported body weight change of 5% or more within 3 months of screening 3. Current or past diagnosis of diabetes mellitus (including type 1, type 2, gestational) 4. Current or past diagnosis of chronic pancreatitis 5. Calcitonin ≥50 ng/L measured by central laboratory at screening (individuals with elevated calcitonin at initial screening may be re-screened) 6. Any GLP-1 receptor agonist or GLP-1/GIP dual agonist within 6 months of Screening 7. Any prescription or over-the-counter medications intended for weight loss within 6 months of screening
Where this trial is running
Peoria, Arizona and 14 other locations
- Viking Clinical Site #111 — Peoria, Arizona, United States (RECRUITING)
- Viking Clinical Site #105 — Lake Forest, California, United States (RECRUITING)
- Viking Clinical Site #101 — Clearwater, Florida, United States (RECRUITING)
- Viking Clinical Site #108 — Largo, Florida, United States (RECRUITING)
- Viking Clinical Site #107 — Ocoee, Florida, United States (RECRUITING)
- Viking Clinical Site #102 — Port Orange, Florida, United States (RECRUITING)
- Viking Clinical Site #100 — Indianapolis, Indiana, United States (RECRUITING)
- Viking Clinical Site #110 — Louisville, Kentucky, United States (RECRUITING)
- Viking Clinical Site #114 — Marrero, Louisiana, United States (RECRUITING)
- Viking Clinical Site #112 — Kansas City, Missouri, United States (RECRUITING)
- Viking Clinical Site #109 — Saint Peters, Missouri, United States (RECRUITING)
- Viking Clinical Site #113 — Butte, Montana, United States (RECRUITING)
- Viking Clinical Site #103 — Knoxville, Tennessee, United States (RECRUITING)
- Viking Clinical Site #104 — Austin, Texas, United States (RECRUITING)
- Viking Clinical Site #106 — San Antonio, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Becky Steele
- Email: bsteele@vikingtherapeutics.com
- Phone: 858-704-4660
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Weight Loss, Overweight Obese