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Phase 1 Study to Evaluate the Safety and Tolerability of VK2735

Primary Purpose

Weight Loss, NASH

Status

Recruiting

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

VK2735

Placebo

VK2735 Placebo

VK2735 Drug

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Viking Clinical SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Placebo (Part A)

VK2735 (Part A)

Placebo (Part B)

VK2735 (Part B)

VK2735 (Part C )

VK2735 (Part C)

Arm Description

Placebo administered SC once in healthy participants

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

Placebo administered SC once weekly for four weeks in healthy participants

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

Placebo administered orally daily for 28 days in healthy participants

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluate the Pharmacokinetic profile of VK2735

Pharmacokinetic profile of VK2735 by measuring peak plasma concentration (Cmax)

Full Information

NCT ID

NCT05203237

First Posted

January 10, 2022

Last Updated

September 12, 2023

Sponsor

Viking Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05203237

Brief Title

Phase 1 Study to Evaluate the Safety and Tolerability of VK2735

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 14, 2021 (Actual)

Primary Completion Date

November 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Viking Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Weight Loss, NASH

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo (Part A)

Arm Type

Placebo Comparator

Arm Description

Placebo administered SC once in healthy participants

Arm Title

VK2735 (Part A)

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo (Part B)

Arm Type

Placebo Comparator

Arm Description

Placebo administered SC once weekly for four weeks in healthy participants

Arm Title

VK2735 (Part B)

Arm Type

Experimental

Arm Description

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

Arm Title

VK2735 (Part C )

Arm Type

Placebo Comparator

Arm Description

Placebo administered orally daily for 28 days in healthy participants

Arm Title

VK2735 (Part C)

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

VK2735

Intervention Description

Administered SC

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

VK2735 Placebo

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

VK2735 Drug

Intervention Description

Administered orally

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

8 days

Secondary Outcome Measure Information:

Title

Evaluate the Pharmacokinetic profile of VK2735

Description

Pharmacokinetic profile of VK2735 by measuring peak plasma concentration (Cmax)

Time Frame

29 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marianne Mancini

Phone

858-704-4674

mmancini@vikingtherapeutics.com

First Name & Middle Initial & Last Name or Official Title & Degree

Becky Steele

Phone

858-704-4687

rsteele@vikingtherapeutics.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marianne Mancini

Organizational Affiliation

Viking Therapeutics, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Viking Clinical Site

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Phase 1 Study to Evaluate the Safety and Tolerability of VK2735

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