Clinical trial NCT06828055: VK2735 for Weight Management Phase 2 (Venture Oral Dosing)
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Weight Loss
Keywords: Overweight Obese
Lead sponsor: Viking Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-02-14
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percent (relative) change from baseline in body weight after 13 weeks of treatment
timeFrame: 13 Weeks
Secondary outcomes:
measure: 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
timeFrame: 13 Weeks
Other outcomes:
measure: Incidence of Treatment-emergent Adverse Events, incidence of Treatment-Emergent Serious Adverse Events and incidence of Adverse Events of Special Interest
timeFrame: 13 Weeks
Locations:
city: Peoria
country: United States
facility: Viking Clinical Site #111
state: Arizona
city: Lake Forest
country: United States
facility: Viking Clinical Site #105
state: California
city: Clearwater
country: United States
facility: Viking Clinical Site #101
state: Florida
city: Largo
country: United States
facility: Viking Clinical Site #108
state: Florida
city: Ocoee
country: United States
facility: Viking Clinical Site #107
state: Florida
city: Port Orange
country: United States
facility: Viking Clinical Site #102
state: Florida
city: Indianapolis
country: United States
facility: Viking Clinical Site #100
state: Indiana
city: Louisville
country: United States
facility: Viking Clinical Site #110
state: Kentucky
city: Marrero
country: United States
facility: Viking Clinical Site #114
state: Louisiana
city: Kansas City
country: United States
facility: Viking Clinical Site #112
state: Missouri
city: Saint Peters
country: United States
facility: Viking Clinical Site #109
state: Missouri
city: Butte
country: United States
facility: Viking Clinical Site #113
state: Montana
city: Knoxville
country: United States
facility: Viking Clinical Site #103
state: Tennessee
city: Austin
country: United States
facility: Viking Clinical Site #104
state: Texas
city: San Antonio
country: United States
facility: Viking Clinical Site #106
state: Texas
Study officials:
References: