VENTURE: VK2735 for Weight Management Phase 2

Sponsor

Viking Therapeutics, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06068946

Collaborator

(none)

125

Enrollment

Locations

Arms

Anticipated Duration (Months)

6.3

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Weight Loss	Biological: VK2735 Biological: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

125 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 31, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: VK2735 (Placebo) Placebo	Biological: Placebo Placebo comparator
Experimental: VK2735 (Dose #1) VK2735 is a peptide GLP-1 and GIP dual agonist	Biological: VK2735 VK2735 is a peptide GLP-1 and GIP dual agonist
Experimental: VK2735 (Dose #2) VK2735 is a peptide GLP-1 and GIP dual agonist	Biological: VK2735 VK2735 is a peptide GLP-1 and GIP dual agonist
Experimental: VK2735 (Dose #3) VK2735 is a peptide GLP-1 and GIP dual agonist	Biological: VK2735 VK2735 is a peptide GLP-1 and GIP dual agonist
Experimental: VK2735 (Dose #4) VK2735 is a peptide GLP-1 and GIP dual agonist	Biological: VK2735 VK2735 is a peptide GLP-1 and GIP dual agonist

Outcome Measures

Primary Outcome Measures

Percent (relative) change from baseline to Week 13 in body weight [13 weeks]
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 [13 weeks]
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

Other Outcome Measures

Incidence of treatment-emergent adverse events (TEAEs), TESAEs, AESI [13 weeks]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Viking Clinical Site #119	Birmingham	Alabama	United States	35235
2	Viking Clinical Site #114	Long Beach	California	United States	90815
3	Viking Clinical Site #110	Los Angeles	California	United States	90057
4	Viking Clinical Site #113	Tustin	California	United States	92780
5	Viking Clinical Site #116	Clearwater	Florida	United States	33756
6	Viking Clinical Site #106	Clearwater	Florida	United States	33761
7	Viking Clinical Site #112	Jacksonville	Florida	United States	32216
8	Viking Clinical Site #105	Ocoee	Florida	United States	34761
9	Viking Clinical Site #107	Port Orange	Florida	United States	32127
10	Viking Clinical Site #104	Indianapolis	Indiana	United States	46260
11	Viking Clinical Site #103	Louisville	Kentucky	United States	40213
12	Viking Clinical Site #109	Marrero	Louisiana	United States	70072
13	Viking Clinical Site #102	Kansas City	Missouri	United States	64131
14	Viking Clinical Site #111	Butte	Montana	United States	59701
15	Viking Clinical Site #108	Knoxville	Tennessee	United States	37920
16	Viking Clinical Site #101	Austin	Texas	United States	78705
17	Viking Clinical Site #118	Austin	Texas	United States	78731
18	Viking Clinical Site #100	Phoenix	Texas	United States	85210
19	Viking Clinical Site #115	San Antonio	Texas	United States	78229
20	Viking Clinical Site #117	San Antonio	Texas	United States	78229

Sponsors and Collaborators

Viking Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Viking Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT06068946

Other Study ID Numbers:

VK2735-201

First Posted:

Oct 5, 2023

Last Update Posted:

Oct 5, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Viking Therapeutics, Inc.

Overweight

Obese

Additional relevant MeSH terms:

Body Weight

Weight Loss

Study Results

No Results Posted as of Oct 5, 2023