VK2735 for Weight Management Phase 2

Weight Loss Clinical Trial

— VENTURE  

Official title:

A Phase 2 Randomized, Double-Blind, Placebo-Controlled, 13-week Study of VK2735 for Weight Management in Subjects Who Are Obese, or Overweight With at Least One Weight-related Comorbid Condition

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06068946
• Other study ID #: VK2735-201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 31, 2023
• Est. completion date: June 2024

Study information

• Verified date: April 2024
• Source: Viking Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 176
• Est. completion date: June 2024
• Est. primary completion date: February 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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 =20 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

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

Biological:
• VK2735
VK2735 is a peptide GLP-1 and GIP dual agonist
• Placebo
Placebo comparator

Locations

Country	Name	City	State
United States	Viking Clinical Site #101	Austin	Texas
United States	Viking Clinical Site #118	Austin	Texas
United States	Viking Clinical Site #119	Birmingham	Alabama
United States	Viking Clinical Site #111	Butte	Montana
United States	Viking Clinical Site #106	Clearwater	Florida
United States	Viking Clinical Site #116	Clearwater	Florida
United States	Viking Clinical Site #104	Indianapolis	Indiana
United States	Viking Clinical Site #112	Jacksonville	Florida
United States	Viking Clinical Site #102	Kansas City	Missouri
United States	Viking Clinical Site #108	Knoxville	Tennessee
United States	Viking Clinical Site #114	Long Beach	California
United States	Viking Clinical Site #110	Los Angeles	California
United States	Viking Clinical Site #103	Louisville	Kentucky
United States	Viking Clinical Site #109	Marrero	Louisiana
United States	Viking Clinical Site #105	Ocoee	Florida
United States	Viking Clinical Site #100	Phoenix	Texas
United States	Viking Clinical Site #107	Port Orange	Florida
United States	Viking Clinical Site #115	San Antonio	Texas
United States	Viking Clinical Site #117	San Antonio	Texas
United States	Viking Clinical Site #113	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
Viking Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of treatment-emergent adverse events (TEAEs), TESAEs, AESI	To evaluate the safety and tolerability of VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition	13 weeks
Primary	Percent (relative) change from baseline to Week 13 in body weight	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	13 weeks
Secondary	Proportion of Subjects losing =5% and =10% of baseline weight at Week 13	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	13 weeks