VK2735 for Weight Management Phase 2
- Registration Number
- NCT06068946
- Lead Sponsor
- Viking Therapeutics, Inc.
- Brief Summary
This is a phase 2, 13-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of VK2735 in adults who are obese (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition.
VK2735 or matched placebo will be administered once weekly.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 176
- Age ≥18 years of age at the time of signing the informed consent
- 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
- History of or current clinically significant medical or psychiatric disorder that, in the opinion of the Investigator, does not support study participation
- Self-reported body weight change of 5% or more within 3 months of screening
- Current or past diagnosis of diabetes mellitus (including type 1, type 2, gestational)
- Current or past diagnosis of chronic pancreatitis
- Calcitonin ≥20 ng/L measured by central laboratory at screening (individuals with elevated calcitonin at initial screening may be re-screened)
- Any GLP-1 receptor agonist or GLP-1/GIP dual agonist within 6 months of Screening
- Any prescription or over-the-counter medications intended for weight loss within 6 months of screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VK2735 (Dose #1) VK2735 VK2735 is a peptide GLP-1 and GIP dual agonist VK2735 (Placebo) Placebo Placebo VK2735 (Dose #4) VK2735 VK2735 is a peptide GLP-1 and GIP dual agonist VK2735 (Dose #2) VK2735 VK2735 is a peptide GLP-1 and GIP dual agonist VK2735 (Dose #3) VK2735 VK2735 is a peptide GLP-1 and GIP dual agonist
- Primary Outcome Measures
Name Time Method Percent (relative) change from baseline to Week 13 in body weight 13 weeks To measure the efficacy of VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition
- Secondary Outcome Measures
Name Time Method Proportion of Subjects losing ≥5% and ≥10% of baseline weight at Week 13 13 weeks To measure the efficacy of VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition
Trial Locations
- Locations (20)
Viking Clinical Site #107
🇺🇸Port Orange, Florida, United States
Viking Clinical Site #101
🇺🇸Austin, Texas, United States
Viking Clinical Site #114
🇺🇸Long Beach, California, United States
Viking Clinical Site #103
🇺🇸Louisville, Kentucky, United States
Viking Clinical Site #102
🇺🇸Kansas City, Missouri, United States
Viking Clinical Site #118
🇺🇸Austin, Texas, United States
Viking Clinical Site #100
🇺🇸Phoenix, Texas, United States
Viking Clinical Site #116
🇺🇸Clearwater, Florida, United States
Viking Clinical Site #105
🇺🇸Ocoee, Florida, United States
Viking Clinical Site #108
🇺🇸Knoxville, Tennessee, United States
Viking Clinical Site #106
🇺🇸Clearwater, Florida, United States
Viking Clinical Site #112
🇺🇸Jacksonville, Florida, United States
Viking Clinical Site #109
🇺🇸Marrero, Louisiana, United States
Viking Clinical Site #119
🇺🇸Birmingham, Alabama, United States
Viking Clinical Site #110
🇺🇸Los Angeles, California, United States
Viking Clinical Site #115
🇺🇸San Antonio, Texas, United States
Viking Clinical Site #113
🇺🇸Tustin, California, United States
Viking Clinical Site #104
🇺🇸Indianapolis, Indiana, United States
Viking Clinical Site #111
🇺🇸Butte, Montana, United States
Viking Clinical Site #117
🇺🇸San Antonio, Texas, United States