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Clinical Trial NCT05203237 for Weight Loss, NASH is completed. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Phase 1 Study to Evaluate the Safety and Tolerability of VK2735 Phase 1 92 Randomized Double-Blind Placebo-Controlled

Completed
Clinical Trial NCT05203237 was designed to study Treatment for Weight Loss, NASH. This was a Phase 1 interventional study that is now completed. The study started on 14 December 2021, with plans to enroll 92 participants. Led by Viking Therapeutics, Inc., the expected completion date was 3 December 2024. The latest data from ClinicalTrials.gov was last updated on 17 February 2025.
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...

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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

Conditions
Weight LossNASH
Other Study IDs
  • VK2735-101
NCT ID Number
NCT05203237
Start Date (Actual)
2021-12-14
Last Update Posted
2025-02-17
Completion Date (Estimated)
2024-12-03
Enrollment (Estimated)
92
Study Type
Interventional
PHASE
Phase 1
Status
Completed
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Placebo ComparatorPlacebo (Part A)
Placebo administered SC once in healthy participants
Placebo
Administered SC
ExperimentalVK2735 (Part A)
Escalating doses of VK2735 administered subcutaneously (SC) once in healthy participants.
VK2735
Administered SC
Placebo ComparatorPlacebo (Part B)
Placebo administered SC once weekly for four weeks in healthy participants
Placebo
Administered SC
ExperimentalVK2735 (Part B)
Escalating doses of VK2735 administered subcutaneously (SC) once weekly in healthy participants.
VK2735
Administered SC
Placebo ComparatorVK2735 (Part C )
Placebo administered orally daily for 28 days in healthy participants
VK2735 Placebo
Administered orally
ExperimentalVK2735 (Part C)
Escalating doses of VK2735 administered daily (PO) in healthy participants.
VK2735 Drug
Administered orally
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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 Measures
Outcome MeasureMeasure DescriptionTime Frame
Evaluate the Pharmacokinetic profile of VK2735
Pharmacokinetic profile of VK2735 by measuring peak plasma concentration (Cmax)
29 days
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes

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

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

Viking Therapeutics, Inc. logoViking Therapeutics, Inc.
No contact data.
1 Study Locations in 1 Countries

South Australia

Viking Clinical Site, Adelaide, South Australia, 5000, Australia