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VK2735 for Weight Management Phase 2 (VENTURE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06068946
Recruitment Status : Active, not recruiting
First Posted : October 5, 2023
Last Update Posted : April 12, 2024
Sponsor:
Information provided by (Responsible Party):
Viking Therapeutics, Inc.

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 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 : August 31, 2023
Actual Primary Completion Date : February 27, 2024
Estimated Study Completion Date : June 2024

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Percent (relative) change from baseline to Week 13 in body weight [ Time Frame: 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 :
  1. Proportion of Subjects losing ≥5% and ≥10% of baseline weight at Week 13 [ Time Frame: 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:
  1. Incidence of treatment-emergent adverse events (TEAEs), TESAEs, AESI [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06068946


Locations
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Sponsors and Collaborators
Viking Therapeutics, Inc.
More Information
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Responsible Party: Viking Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT06068946    
Other Study ID Numbers: VK2735-201
First Posted: October 5, 2023    Key Record Dates
Last Update Posted: April 12, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Viking Therapeutics, Inc.:
Overweight
Obese
Additional relevant MeSH terms:
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Body Weight
Weight Loss
Body Weight Changes