← Trials/Trial dossier/NCT05203237
Phase 1 Study to Evaluate the Safety and Tolerability of VK2735
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
Lead sponsor
Asset
VK2735
Subcutaneous · GLP-1 / GIP dual
Listed sites
1
Recruiting sites
—
Enrollment
92
actual
Study population
Healthy volunteers, Obesity / overweight
Key I/E criterion
•Healthy volunteers
Primary endpoint
•Treatment-emergent AEs (any) (Treatment-emergent AEs (any), Serious AEs (any))
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Endpoints (2)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Safety / tolerability / PK
2 endpointsIncidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious AEs (TESAEs)
Time frame:8 days
Treatment-emergent AEs (any)
event count, event
componentsTreatment-emergent AEs (any), Serious AEs (any)
Evaluate the Pharmacokinetic profile of VK2735
Time frame:29 days
Cmax
concentration, descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.