NCT05203237

Phase 1 Study to Evaluate the Safety and Tolerability of VK2735

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VK2735, a Dual Glucagon-like Peptide-1 and Gastric Inhibitory Polypeptide Receptor Agonist, in Healthy Adults and Otherwise Healthy Adults Who Have an Increased Body Mass Index

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Viking Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, randomized, double-blind, placebo-controlled single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VK2735 in healthy adults and otherwise healthy adults who have an increased body mass index (BMI).

Detailed description

This study comprises 3 parts: Part A (Single Ascending Dose \[SAD\]) will be conducted to assess the safety, tolerability, and PK profile in healthy participants following 1 single SC injection of VK2735 or VK2735 matching placebo (SAD Cohort 1 through SAD Cohort 6). Part B (Multiple Ascending Dose \[MAD\]) will be conducted to assess the safety, tolerability, PK and PD profile in otherwise healthy participants who have an increased BMI following single SC injections of VK2735 or matched placebo administered once weekly for 4 consecutive weeks (MAD Cohort 1 through MAD Cohort 5). Part C (Multiple Ascending Dose \[MAD\], PO) will be conducted to assess the safety, tolerability, PK and PD profiles in otherwise healthy, but obese, participants who have a BMI ≥30 kg/m2 following daily oral administration of VK2735 or matched placebo administered for 28 consecutive days (MAD-PO Cohort 1 through MAD-PO Cohort 4, with optional additional cohorts) Safety Review Committee (SRC) meetings will be held prior to dose escalation for Part A (SAD), Part B (MAD), and Part C (MAD-PO) cohorts in the study. The decisions on dose escalation will be based on safety and laboratory data from each cohort.

Conditions

• Weight Loss
• NASH

Interventions

Type	Name	Description
BIOLOGICAL	VK2735	Administered SC
BIOLOGICAL	Placebo	Administered SC
DRUG	VK2735 Placebo	Administered orally
DRUG	VK2735 Drug	Administered orally

Timeline

• Start date: 2021-12-14
• Primary completion: 2024-11-04
• Completion: 2024-12-03
• First posted: 2022-01-24
• Last updated: 2025-02-17

Locations

1 site across 1 country: Australia