Phase 1 Study to Evaluate the Safety and Tolerability of VK2735

NCT05203237 | Completed Phase 1 DMC

• 1 other identifier: VK2735-101
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Weight Loss; NASH

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious AEs (TESAEs)

  To evaluate the safety and tolerability of single doses of subcutaneous injections of VK2735 in healthy participants

  8 days

Secondary Outcomes (1)

• Evaluate the Pharmacokinetic profile of VK2735

  29 days

Study Arms (6)

Placebo (Part A)

PLACEBO COMPARATOR

Placebo administered SC once in healthy participants

Biological: Placebo

VK2735 (Part A)

EXPERIMENTAL

Escalating doses of VK2735 administered subcutaneously (SC) once in healthy participants.

Biological: VK2735

Placebo (Part B)

PLACEBO COMPARATOR

Placebo administered SC once weekly for four weeks in healthy participants

Biological: Placebo

VK2735 (Part B)

EXPERIMENTAL

Escalating doses of VK2735 administered subcutaneously (SC) once weekly in healthy participants.

Biological: VK2735

VK2735 (Part C )

PLACEBO COMPARATOR

Placebo administered orally daily for 28 days in healthy participants

Drug: VK2735 Placebo

VK2735 (Part C)

EXPERIMENTAL

Escalating doses of VK2735 administered daily (PO) in healthy participants.

Drug: VK2735 Drug

Interventions

VK2735 BIOLOGICAL

Administered SC

VK2735 (Part A); VK2735 (Part B)

Placebo BIOLOGICAL

Administered SC

Placebo (Part A); Placebo (Part B)

VK2735 Placebo DRUG

Administered orally

VK2735 (Part C )

VK2735 Drug DRUG

Administered orally

VK2735 (Part C)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be capable of giving signed informed consent
• Participants must be medically healthy, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening and/or before administration of the initial dose of IP in the opinion of the Investigator
• Participant body weight must have been stable (no change greater than 5%) for a minimum 8 weeks prior to Screening
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other clinical study procedures
• Willing to comply with contraception requirements

You may not qualify if:

• Participants with any level of disease or organ system dysfunction as identified during physical examination, medical history or laboratory testing, as assessed by the PI
• Any surgical or medical condition (active or chronic) that may interfere with IP distribution, metabolism, excretion, or drug absorption
• Participants may be excluded from the study if they have conditions that might compromise safety or other endpoints in the study as judged by the Sponsor (or designee) or Investigator
• History or presence of clinically significant acute or unstable cerebrovascular (stroke), hepatic, renal, gastrointestinal, pulmonary, immunological, endocrine, diabetes, hematological, oncological, or central nervous disorder that in the opinion of the Investigator would pose a significant risk for the participant
• Use of any investigational drug or product, or participation in an investigational drug study within 30 days prior to dosing or 5 half-lives of the drug (whichever is longest)
• Active smoker and/or user of nicotine-containing products unless the participant agrees to discontinue smoking/use of nicotine-containing products from 2 weeks before first IP dose administration through to study completion, including the Follow-up period
• Have serum triglycerides \> 5.65 mmol/L (500 mg/dL) at Screening
• Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or HIV

Sponsors & Collaborators

• Viking Therapeutics, Inc.: lead

Study Sites (1)

Viking Clinical Site

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

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

Study Officials

• Marianne Mancini

  Viking Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 24, 2022
• Study Start: December 14, 2021
• Primary Completion: November 4, 2024
• Study Completion: December 3, 2024
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)