About this trial
The primary objective is to evaluate the safety and tolerability of VRB-103 tablets administered as monotherapy or VRB-103 tablets administered in combination with oral ecnoglutide tablets (VRB-101 tablets) in a single-dose regimen or in a multiple dose regimen.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female assigned at birth, inclusive of all gender identities.
Have HbA1c ≤6.4% at Screening and Day -2 eligibility confirmation.
≥25 kg/m² and ≤35.0 kg/m² (Arm 1) OR
≥27 kg/m² and ≤40.0 kg/m² (Arm 2 and Arm 3)
Disqualifiers
Have any prior diagnosis of type 1 diabetes mellitus or T2DM, or other forms of diabetes mellitus. A participant with a history of gestational diabetes may be included in the study if the participant has HbA1c ≤6.4% at Screening and Day -2 eligibility confirmation and is not on medication to lower glucose.
Have at least 1 laboratory value suggestive of diabetes at Screening and Day -2 eligibility confirmation, including 1 or more of HbA1c >6.4% (48 mmol/mol) or random glucose ≥200 mg/dL (11.1 mmol/L).
Have had exposure to GLP-1, glucose-dependent insulinotropic peptide (GIP), or amylin analogs within 6 months prior to Screening or any prior history of known or suspected hypersensitivity/allergies, intolerability, or lack of efficacy to these medications. Have known or suspected hypersensitivity to study product(s), to amylin analogs, to selective GLP-1 receptor agonist (RAs), or to GIP/GLP-1 or GLP-1/glucagon dual RAs.
Presence or history of clinically significant cardiovascular, renal, hepatic, dermatological, respiratory, neurological, psychiatric, malignant, metabolic, endocrinological, hematological, or venereal disorder, as judged by the Investigator.
Trial design
Parallel
Treatments tested in this trial
VRB-103
DrugVRB-103 tablets will be administered orally.
Placebo
Other interventionPlacebo tablets will be administered orally.
VRB-101
DrugVRB-101 tablets will be administered orally.
Treatment groups
Trial outcomes
Primary outcomes
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Any clinically significant changes in lab parameters, hematology, ECG parameters, will be reported as TEAEs.
Number of Participants with Adverse Events of Special Interest (AESIs)
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) from Baseline
The C-SSRS systematically assesses suicidal ideation and behavior using yes/no questions, ordinal severity ratings (0-5), and intensity subscales. Results at End of Study will be compared to Baseline.
Change in Patient Health Questionnaire-9 (PHQ-9) Scores from Baseline
The PHQ-9 is a 9-item validated assessment, measures the severity of depression. Each item is rated from 0 to 3, for a total score out of 27. A score of 15-19 indicates moderately severe depression, and a score of 20-27 indicates severe depression.
Secondary outcomes
Plasma concentrations of VRB-103 and VRB-101
Maximum Observed Plasma Concentration (Cmax) for VRB-103 and VRB-101
Time to Reach Cmax (Tmax) for VRB-103 and VRB-101
Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUCinf) for VRB-103 and VRB-101
Sponsors and contacts
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