VK2735 for Weight Management Phase 2 (Venture Oral Dosing)

NCT06828055 | Completed Phase 2 FDA Drug

• 1 other identifier: VK2735-202
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 15

Brief Summary

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.

Conditions

Weight Loss

Keywords

Overweight Obese

Outcome Measures

Primary Outcomes (1)

• Percent (relative) change from baseline in body weight after 13 weeks of treatment

  To measure the efficacy of oral VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition

  13 Weeks

Secondary Outcomes (1)

• Proportion of Subjects losing ≥5% and ≥10% of baseline weight at Week 13. Observed and change from baseline in body weight (kg) after 13 weeks of treatment

  13 Weeks

Other Outcomes (1)

• Incidence of Treatment-emergent Adverse Events, incidence of Treatment-Emergent Serious Adverse Events and incidence of Adverse Events of Special Interest

  13 Weeks

Study Arms (7)

Placebo Assignment

PLACEBO COMPARATOR

VK2735 (Placebo) administered Daily

Drug: Placebo

Active Assignment (Dose #1)

EXPERIMENTAL

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

Drug: VK2735

Active Assignment (Dose #2)

EXPERIMENTAL

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

Drug: VK2735

Active Assignment (Dose #3)

EXPERIMENTAL

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

Drug: VK2735

Active Assignment (Dose #4)

EXPERIMENTAL

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

Drug: VK2735

Active Assignment (Dose #5)

EXPERIMENTAL

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

Drug: VK2735

Active Assignment (Dose #6)

EXPERIMENTAL

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

Drug: VK2735

Interventions

Placebo DRUG

Matching Placebo to VK2735

Placebo Assignment

VK2735 DRUG

Active Treatment

Active Assignment (Dose #1); Active Assignment (Dose #2); Active Assignment (Dose #3); Active Assignment (Dose #4); Active Assignment (Dose #5); Active Assignment (Dose #6)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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 ≥50 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

Sponsors & Collaborators

• Viking Therapeutics, Inc.: lead

Study Sites (15)

Viking Clinical Site #111

Peoria, Arizona, 85381, United States

Location

Viking Clinical Site #105

Lake Forest, California, 96230, United States

Location

Viking Clinical Site #101

Clearwater, Florida, 33756, United States

Location

Viking Clinical Site #108

Largo, Florida, 33777, United States

Location

Viking Clinical Site #107

Ocoee, Florida, 34761, United States

Location

Viking Clinical Site #102

Port Orange, Florida, 32127, United States

Location

Viking Clinical Site #100

Indianapolis, Indiana, 46260, United States

Location

Viking Clinical Site #110

Louisville, Kentucky, 40213, United States

Location

Viking Clinical Site #114

Marrero, Louisiana, 70072, United States

Location

Viking Clinical Site #109

City of Saint Peters, Missouri, 63303, United States

Location

Viking Clinical Site #112

Kansas City, Missouri, 64131, United States

Location

Viking Clinical Site #113

Butte, Montana, 59701, United States

Location

Viking Clinical Site #103

Knoxville, Tennessee, 37909, United States

Location

Viking Clinical Site #104

Austin, Texas, 78705, United States

Location

Viking Clinical Site #106

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 14, 2025
• Study Start: December 18, 2024
• Primary Completion: June 24, 2025
• Study Completion: August 15, 2025
• Last Updated: October 6, 2025

Record last verified: 2025-09

Locations

US (15)