VK2735 for Weight Management Phase 2 (Venture Oral Dosing)

NCT ID: NCT06828055

Last Updated: 2025-10-06

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

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-18

Study Completion Date

2025-08-15

Brief Summary

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This is a phase 2, 13-week randomized, double-blind, placebo-controlled, parallel arm dose-finding study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of VK2735 Oral Formulation 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 daily.

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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Placebo Assignment

VK2735 (Placebo) administered Daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching Placebo to VK2735

Active Assignment (Dose #1)

VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily

Group Type EXPERIMENTAL

VK2735

Intervention Type DRUG

Active Treatment

Active Assignment (Dose #2)

VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily

Group Type EXPERIMENTAL

VK2735

Intervention Type DRUG

Active Treatment

Active Assignment (Dose #3)

VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily

Group Type EXPERIMENTAL

VK2735

Intervention Type DRUG

Active Treatment

Active Assignment (Dose #4)

VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily

Group Type EXPERIMENTAL

VK2735

Intervention Type DRUG

Active Treatment

Active Assignment (Dose #5)

VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily

Group Type EXPERIMENTAL

VK2735

Intervention Type DRUG

Active Treatment

Active Assignment (Dose #6)

VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily

Group Type EXPERIMENTAL

VK2735

Intervention Type DRUG

Active Treatment

Interventions

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Placebo

Matching Placebo to VK2735

Intervention Type DRUG

VK2735

Active Treatment

Intervention Type DRUG

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

* Weight-related co-morbid conditions include hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease.
* BMI calculated at the Screening visit will be used to determine eligibility.

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 ≥50 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 #111

Peoria, Arizona, United States

Site Status

Viking Clinical Site #105

Lake Forest, California, United States

Site Status

Viking Clinical Site #101

Clearwater, Florida, United States

Site Status

Viking Clinical Site #108

Largo, Florida, United States

Site Status

Viking Clinical Site #107

Ocoee, Florida, United States

Site Status

Viking Clinical Site #102

Port Orange, Florida, United States

Site Status

Viking Clinical Site #100

Indianapolis, Indiana, United States

Site Status

Viking Clinical Site #110

Louisville, Kentucky, United States

Site Status

Viking Clinical Site #114

Marrero, Louisiana, United States

Site Status

Viking Clinical Site #109

City of Saint Peters, Missouri, United States

Site Status

Viking Clinical Site #112

Kansas City, Missouri, United States

Site Status

Viking Clinical Site #113

Butte, Montana, United States

Site Status

Viking Clinical Site #103

Knoxville, Tennessee, United States

Site Status

Viking Clinical Site #104

Austin, Texas, United States

Site Status

Viking Clinical Site #106

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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VK2735-202

Identifier Type: -

Identifier Source: org_study_id

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