Phase 1 Study to Evaluate the Safety and Tolerability of VK2735

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05203237
• Other study ID #: VK2735-101
• Status: Recruiting
• Phase: Phase 1
• Start date: December 14, 2021
• Est. completion date: December 2023

Study information

• Verified date: September 2023
• Source: Viking Therapeutics, Inc.
• Contact: Marianne Mancini
• Phone: 858-704-4674
• Email: mmancini[@]vikingtherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• NASH
• Weight Loss

Intervention

Biological:
• VK2735
Administered SC
• Placebo
Administered SC

Drug:
• VK2735 Placebo
Administered orally
• VK2735 Drug
Administered orally

Locations

Country	Name	City	State
Australia	Viking Clinical Site	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
Viking Therapeutics, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate the Pharmacokinetic profile of VK2735	Pharmacokinetic profile of VK2735 by measuring peak plasma concentration (Cmax)	29 days