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Phase 1 Study to Evaluate the Safety and Tolerability of VK2735
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).
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2021-12-14
Primary completion: 2023-11-01
Study completion finish: 2023-12-01
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT05203237
Intervention or treatment
BIOLOGICAL: VK2735
BIOLOGICAL: Placebo
DRUG: VK2735 Placebo
DRUG: VK2735 Drug
Conditions
- • NASH
- • Weight Loss
Find a site
Closest Location:
Viking Clinical Site
Research sites nearby
Select from list below to view details:
Viking Clinical Site
Adelaide, South Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo (Part A)
| BIOLOGICAL: Placebo
|
EXPERIMENTAL: VK2735 (Part A)
| BIOLOGICAL: VK2735
|
PLACEBO_COMPARATOR: Placebo (Part B)
| BIOLOGICAL: Placebo
|
EXPERIMENTAL: VK2735 (Part B)
| BIOLOGICAL: VK2735
|
PLACEBO_COMPARATOR: VK2735 (Part C )
| DRUG: VK2735 Placebo
|
EXPERIMENTAL: VK2735 (Part C)
| DRUG: VK2735 Drug
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
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 outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Evaluate the Pharmacokinetic profile of VK2735 | Pharmacokinetic profile of VK2735 by measuring peak plasma concentration (Cmax) | 29 days |
Frequently Asked Questions
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