VK2735 for Weight Management Phase 2

NCT ID: NCT06068946

Last Updated: 2025-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-31

Study Completion Date

2024-04-02

Brief Summary

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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.

Detailed Description

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Conditions

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Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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VK2735 (Placebo)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo comparator

VK2735 (Dose #1)

VK2735 is a peptide GLP-1 and GIP dual agonist

Group Type EXPERIMENTAL

VK2735

Intervention Type BIOLOGICAL

VK2735 is a peptide GLP-1 and GIP dual agonist

VK2735 (Dose #2)

VK2735 is a peptide GLP-1 and GIP dual agonist

Group Type EXPERIMENTAL

VK2735

Intervention Type BIOLOGICAL

VK2735 is a peptide GLP-1 and GIP dual agonist

VK2735 (Dose #3)

VK2735 is a peptide GLP-1 and GIP dual agonist

Group Type EXPERIMENTAL

VK2735

Intervention Type BIOLOGICAL

VK2735 is a peptide GLP-1 and GIP dual agonist

VK2735 (Dose #4)

VK2735 is a peptide GLP-1 and GIP dual agonist

Group Type EXPERIMENTAL

VK2735

Intervention Type BIOLOGICAL

VK2735 is a peptide GLP-1 and GIP dual agonist

Interventions

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VK2735

VK2735 is a peptide GLP-1 and GIP dual agonist

Intervention Type BIOLOGICAL

Placebo

Placebo comparator

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Viking Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Viking Clinical Site #119

Birmingham, Alabama, United States

Site Status

Viking Clinical Site #114

Long Beach, California, United States

Site Status

Viking Clinical Site #110

Los Angeles, California, United States

Site Status

Viking Clinical Site #113

Tustin, California, United States

Site Status

Viking Clinical Site #116

Clearwater, Florida, United States

Site Status

Viking Clinical Site #106

Clearwater, Florida, United States

Site Status

Viking Clinical Site #112

Jacksonville, Florida, United States

Site Status

Viking Clinical Site #105

Ocoee, Florida, United States

Site Status

Viking Clinical Site #107

Port Orange, Florida, United States

Site Status

Viking Clinical Site #104

Indianapolis, Indiana, United States

Site Status

Viking Clinical Site #103

Louisville, Kentucky, United States

Site Status

Viking Clinical Site #109

Marrero, Louisiana, United States

Site Status

Viking Clinical Site #102

Kansas City, Missouri, United States

Site Status

Viking Clinical Site #111

Butte, Montana, United States

Site Status

Viking Clinical Site #108

Knoxville, Tennessee, United States

Site Status

Viking Clinical Site #101

Austin, Texas, United States

Site Status

Viking Clinical Site #118

Austin, Texas, United States

Site Status

Viking Clinical Site #100

Phoenix, Texas, United States

Site Status

Viking Clinical Site #115

San Antonio, Texas, United States

Site Status

Viking Clinical Site #117

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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VK2735-201

Identifier Type: -

Identifier Source: org_study_id

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