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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05203237




Registration number
NCT05203237
Ethics application status
Date submitted
10/01/2022
Date registered
24/01/2022

Titles & IDs
Public title
Phase 1 Study to Evaluate the Safety and Tolerability of VK2735
Scientific 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
Secondary ID [1] 0 0
VK2735-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Weight Loss 0 0
NASH 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - VK2735
Treatment: Other - Placebo
Treatment: Drugs - VK2735 Placebo
Treatment: Drugs - VK2735 Drug

Placebo comparator: Placebo (Part A) - Placebo administered SC once in healthy participants

Experimental: VK2735 (Part A) - Escalating doses of VK2735 administered subcutaneously (SC) once in healthy participants.

Placebo comparator: Placebo (Part B) - Placebo administered SC once weekly for four weeks in healthy participants

Experimental: VK2735 (Part B) - Escalating doses of VK2735 administered subcutaneously (SC) once weekly in healthy participants.

Placebo comparator: VK2735 (Part C ) - Placebo administered orally daily for 28 days in healthy participants

Experimental: VK2735 (Part C) - Escalating doses of VK2735 administered daily (PO) in healthy participants.


Treatment: Other: VK2735
Administered SC

Treatment: Other: Placebo
Administered SC

Treatment: Drugs: VK2735 Placebo
Administered orally

Treatment: Drugs: VK2735 Drug
Administered orally
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious AEs (TESAEs)
Timepoint [1] 0 0
8 days
Secondary outcome [1] 0 0
Evaluate the Pharmacokinetic profile of VK2735
Timepoint [1] 0 0
29 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
136
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Viking Clinical Site - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Viking Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marianne Mancini
Address 0 0
Viking Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Marianne Mancini
Address 0 0
Country 0 0
Phone 0 0
858-704-4674
Fax 0 0
Email 0 0
mmancini@vikingtherapeutics.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05203237