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VK2735 for Weight Management Phase 2 (VENTURE)

Primary Purpose

Weight Loss

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VK2735
Placebo
Sponsored by
Viking Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss focused on measuring Overweight, Obese

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥18 years of age at the time of signing the informed consent 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: History of or current clinically significant medical or psychiatric disorder that, in the opinion of the Investigator, does not support study participation Self-reported body weight change of 5% or more within 3 months of screening Current or past diagnosis of diabetes mellitus (including type 1, type 2, gestational) Current or past diagnosis of chronic pancreatitis Calcitonin ≥20 ng/L measured by central laboratory at screening (individuals with elevated calcitonin at initial screening may be re-screened) Any GLP-1 receptor agonist or GLP-1/GIP dual agonist within 6 months of Screening Any prescription or over-the-counter medications intended for weight loss within 6 months of screening

Sites / Locations

  • Viking Clinical Site #119Recruiting
  • Viking Clinical Site #114Recruiting
  • Viking Clinical Site #110Recruiting
  • Viking Clinical Site #113Recruiting
  • Viking Clinical Site #116Recruiting
  • Viking Clinical Site #106Recruiting
  • Viking Clinical Site #112Recruiting
  • Viking Clinical Site #105Recruiting
  • Viking Clinical Site #107Recruiting
  • Viking Clinical Site #104Recruiting
  • Viking Clinical Site #103Recruiting
  • Viking Clinical Site #109Recruiting
  • Viking Clinical Site #102Recruiting
  • Viking Clinical Site #111Recruiting
  • Viking Clinical Site #108Recruiting
  • Viking Clinical Site #101Recruiting
  • Viking Clinical Site #118Recruiting
  • Viking Clinical Site #100Recruiting
  • Viking Clinical Site #115Recruiting
  • Viking Clinical Site #117Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

VK2735 (Placebo)

VK2735 (Dose #1)

VK2735 (Dose #2)

VK2735 (Dose #3)

VK2735 (Dose #4)

Arm Description

Placebo

VK2735 is a peptide GLP-1 and GIP dual agonist

VK2735 is a peptide GLP-1 and GIP dual agonist

VK2735 is a peptide GLP-1 and GIP dual agonist

VK2735 is a peptide GLP-1 and GIP dual agonist

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 28, 2023
Last Updated
September 28, 2023
Sponsor
Viking Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06068946
Brief Title
VK2735 for Weight Management Phase 2
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Viking Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
Keywords
Overweight, Obese

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VK2735 (Placebo)
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
VK2735 (Dose #1)
Arm Type
Experimental
Arm Description
VK2735 is a peptide GLP-1 and GIP dual agonist
Arm Title
VK2735 (Dose #2)
Arm Type
Experimental
Arm Description
VK2735 is a peptide GLP-1 and GIP dual agonist
Arm Title
VK2735 (Dose #3)
Arm Type
Experimental
Arm Description
VK2735 is a peptide GLP-1 and GIP dual agonist
Arm Title
VK2735 (Dose #4)
Arm Type
Experimental
Arm Description
VK2735 is a peptide GLP-1 and GIP dual agonist
Intervention Type
Biological
Intervention Name(s)
VK2735
Intervention Description
VK2735 is a peptide GLP-1 and GIP dual agonist
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo comparator
Primary Outcome Measure Information:
Title
Percent (relative) change from baseline to Week 13 in body weight
Description
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
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Proportion of Subjects losing ≥5% and ≥10% of baseline weight at Week 13
Description
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
Time Frame
13 weeks
Other Pre-specified Outcome Measures:
Title
Incidence of treatment-emergent adverse events (TEAEs), TESAEs, AESI
Description
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
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years of age at the time of signing the informed consent 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: History of or current clinically significant medical or psychiatric disorder that, in the opinion of the Investigator, does not support study participation Self-reported body weight change of 5% or more within 3 months of screening Current or past diagnosis of diabetes mellitus (including type 1, type 2, gestational) Current or past diagnosis of chronic pancreatitis Calcitonin ≥20 ng/L measured by central laboratory at screening (individuals with elevated calcitonin at initial screening may be re-screened) Any GLP-1 receptor agonist or GLP-1/GIP dual agonist within 6 months of Screening Any prescription or over-the-counter medications intended for weight loss within 6 months of screening
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Scott Stubbe
Phone
858-704-4660
Ext
4685
Email
sstubbe@vikingtherapeutics.com
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Herman
Phone
858-704-4660
Ext
4694
Email
sherman@vikingtherapeutics.com
Facility Information:
Facility Name
Viking Clinical Site #119
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Andringa
Facility Name
Viking Clinical Site #114
City
Long Beach
State/Province
California
ZIP/Postal Code
90815
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yamil Verganza
Facility Name
Viking Clinical Site #110
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lourdes Garibay
Facility Name
Viking Clinical Site #113
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisseth Granados
Facility Name
Viking Clinical Site #116
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracey Osborn
Facility Name
Viking Clinical Site #106
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabrielle Jackson
Facility Name
Viking Clinical Site #112
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taylor Johnson
Facility Name
Viking Clinical Site #105
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milko Lopez
Facility Name
Viking Clinical Site #107
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracey Matthews
Facility Name
Viking Clinical Site #104
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arthena McBuddy
Facility Name
Viking Clinical Site #103
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Keiran
Facility Name
Viking Clinical Site #109
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alyce Fields
Facility Name
Viking Clinical Site #102
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taleah Brown
Facility Name
Viking Clinical Site #111
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Misty Johnson
Facility Name
Viking Clinical Site #108
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzann Cloninger
Facility Name
Viking Clinical Site #101
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krissandra Johnson-Nealey
Facility Name
Viking Clinical Site #118
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Stewart
Facility Name
Viking Clinical Site #100
City
Phoenix
State/Province
Texas
ZIP/Postal Code
85210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Gil del Real
Facility Name
Viking Clinical Site #115
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daphne Rodriguez
Facility Name
Viking Clinical Site #117
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Mendez

12. IPD Sharing Statement

Learn more about this trial

VK2735 for Weight Management Phase 2

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