COMPLETED

VK2735 for Weight Management Phase 2 (Venture Oral Dosing)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2024-12-18

Study Completion:2025-08-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06828055

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Locations (Sites)

Viking Clinical Site #111

Peoria, Arizona, 85381

United States

Viking Clinical Site #105

Lake Forest, California, 96230

United States

Viking Clinical Site #101

Clearwater, Florida, 33756

United States

Viking Clinical Site #108

Largo, Florida, 33777

United States

Viking Clinical Site #107

Ocoee, Florida, 34761

United States

Viking Clinical Site #102

Port Orange, Florida, 32127

United States

Viking Clinical Site #100

Indianapolis, Indiana, 46260

United States

Viking Clinical Site #110

Louisville, Kentucky, 40213

United States

Viking Clinical Site #114

Marrero, Louisiana, 70072

United States

Viking Clinical Site #109

City of Saint Peters, Missouri, 63303

United States

Viking Clinical Site #112

Kansas City, Missouri, 64131

United States

Viking Clinical Site #113

Butte, Montana, 59701

United States

Viking Clinical Site #103

Knoxville, Tennessee, 37909

United States

Viking Clinical Site #104

Austin, Texas, 78705

United States

Viking Clinical Site #106

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: Viking Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-18

Study Completion Date2025-08-15

Study Record Updates

Study Start Date2024-12-18

Study Completion Date2025-08-15

Terms related to this study

Keywords Provided by Researchers

Overweight Obese

Additional Relevant MeSH Terms

Weight Loss