A Phase 1 Study of VK2735 in Obese Adults Without Comorbidities
ConditionObese Adults
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorViking Therapeutics, Inc.
About this trial
The goal of this Phase 1, randomized, double-blind, placebo-controlled study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of VK2735 in adults who are obese (BMI ≥ 30 kg/m2) without comorbidities.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must be capable of giving a signed informed consent form (ICF).
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 study Investigator.
BMI ≥ 30 kg/m2.
Willing to comply with contraceptive requirements.
Disqualifiers
Participants with any level of disease or organ system dysfunction as identified during physical examination, medical history, or laboratory testing, as assessed by the Investigator.
Any surgical or medical condition (active or chronic) that may interfere with IP distribution, metabolism, excretion or drug absorption.
Any condition 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, hematological, oncological, or central nervous disorder that in the opinion of the Investigator would pose a significant risk for the participant.
Trial design
Design model
Parallel
Treatments tested in this trial
VK2735 Drug
DrugSC or oral once daily, once weekly, every other week, or monthly
Placebo
DrugSC or oral once daily or once weekly
Treatment groups
270 Participants
are divided into 18 treatment groups18
Treatment groupsSee each treatment group below.
Group A: PlaceboPlacebo comparator 1 intervention
Group B: VK2735 Dose Level 2Experimental treatment 2 interventions
Group C: VK2735 Dose Level 3Experimental treatment 1 intervention
Group D: VK2735 Dose Level 4Experimental treatment 1 intervention
Group E: VK2735 Dose Level 5Experimental treatment 1 intervention
Group F: VK2735 Dose Level 6Experimental treatment 1 intervention
Group G: VK2735 Dose Level 7Experimental treatment 1 intervention
Group H: VK2735 Dose Level 8Experimental treatment 1 intervention
Group I: VK2735 Dose Level 9Experimental treatment 1 intervention
Group J: VK2735 Dose Level 10Experimental treatment 1 intervention
Group K: VK2735 Dose Level 11Experimental treatment 1 intervention
Group L: VK2735 Dose Level 12Experimental treatment 2 interventions
Group M: VK2735 Dose Level 14Experimental treatment 1 intervention
Group N: VK2735 Dose Level 15Experimental treatment 1 intervention
Group O: VK2735 Dose Level 16Experimental treatment 1 intervention
Group P: VK2735 Dose Level 17Experimental treatment 2 interventions
Group Q: VK2735 Dose Level 18Experimental treatment 2 interventions
Group R: VK2735 Dose Level 13Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate the Safety and Tolerability VK2735
-Incidence of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)
Time frame
33 weeksSecondary outcomes
1
Evaluate the Pharmacokinetic profile of VK23735
Pharmacokinetic profile of SC VK2735 by measuring peak plasma concentration (Cmax) after weekly, every other week, or monthly administration; Pharmacokinetic profile of oral VK2735 by measuring peak plasma concentration (Cmax) after daily or weekly administration
Time frame
38 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov