VK2735 for Weight Management Phase 2 (Venture Oral Dosing)

Description

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.

Conditions

Weight Loss

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Study Overview

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Study Details

Study overview

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.

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

VK2735 for Weight Management Phase 2 (Venture Oral Dosing)

Condition
Weight Loss
Intervention / Treatment

-

Contacts and Locations

Peoria

Viking Clinical Site #111, Peoria, Arizona, United States, 85381

Lake Forest

Viking Clinical Site #105, Lake Forest, California, United States, 96230

Clearwater

Viking Clinical Site #101, Clearwater, Florida, United States, 33756

Largo

Viking Clinical Site #108, Largo, Florida, United States, 33777

Ocoee

Viking Clinical Site #107, Ocoee, Florida, United States, 34761

Port Orange

Viking Clinical Site #102, Port Orange, Florida, United States, 32127

Indianapolis

Viking Clinical Site #100, Indianapolis, Indiana, United States, 46260

Louisville

Viking Clinical Site #110, Louisville, Kentucky, United States, 40213

Marrero

Viking Clinical Site #114, Marrero, Louisiana, United States, 70072

Kansas City

Viking Clinical Site #112, Kansas City, Missouri, United States, 64131

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Viking Therapeutics, Inc.,

Study Record Dates

2025-11