Weight Loss
Conditions
Keywords
Overweight Obese
Brief summary
This is a phase 2, 13-week randomized, double-blind, placebo-controlled, parallel arm dose-finding study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of VK2735 Oral Formulation 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 daily.
Interventions
DRUGPlacebo
Matching Placebo to VK2735
DRUGVK2735
Active Treatment
Sponsors
Viking Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent (relative) change from baseline in body weight after 13 weeks of treatment | 13 Weeks | To measure the efficacy of oral VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects losing ≥5% and ≥10% of baseline weight at Week 13. Observed and change from baseline in body weight (kg) after 13 weeks of treatment | 13 Weeks | To measure the efficacy of oral VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-emergent Adverse Events, incidence of Treatment-Emergent Serious Adverse Events and incidence of Adverse Events of Special Interest | 13 Weeks | To evaluate the safety and tolerability of oral VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition |
Countries
United States
Outcome results
None listed