A Trial of Oral VRB-103 Alone or in Combination With Oral Ecnoglutide (VRB-101) in Participants With Obesity or Overweight
A Randomized, Double-blind, Placebo-controlled, First-in-Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral VRB-103 Alone or in Combination With Oral Ecnoglutide (VRB-101) in Participants With Obesity or Overweight
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Fase 1
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Verdiva Bio Medical Affairs
- Email: medical.affairs@verdivabio.com
Luoghi di studio
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Melbourne, Australia
- Reclutamento
- Nucleus Network
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Male or female assigned at birth, inclusive of all gender identities.
- Have HbA1c ≤6.4% at Screening and Day -2 eligibility confirmation.
Have a BMI of:
- ≥25 kg/m^2 and ≤35.0 kg/m^2 (Part A) OR
- ≥27 kg/m^2 and ≤40.0 kg/m^2 (Part B and Part C)
- Weight ≥70 kg with self-reported stable body weight (≤5% body weight change) for the 3 months prior to randomization.
- Otherwise healthy, as defined by the absence of any clinically significant, in the Investigator's opinion, active or chronic disease (e.g., Type 2 diabetes mellitus [T2DM], cardiovascular [CV] disease, cancer, and any acute or chronic illness that could pose a problem to completing the study) as determined through a comprehensive medical and surgical history, a thorough physical exam (PE) that includes vital signs, a 12-lead Electrocardiogram (ECG), hematology, blood chemistry, serology, and urinalysis. Cardiovascular (CV) risk factors, such as dyslipidemia and mild hypertension, are expected and are allowed.
- Have an estimated glomerular filtration rate (eGFR) >60 mL/min at Screening and Day -2 eligibility confirmation, as calculated using the 2021 Chronic Kidney Disease Epidemiology (CKD-EPI) creatinine equation, with no other clinical or laboratory evidence of renal dysfunction or impairment.
- Persons of childbearing potential must be non-pregnant and non-lactating and must agree to use study-specified contraceptive methods.
- Have a resting BP of ≤140/90 millimeters of mercury (mmHg) at Screening and Day -2 eligibility with 2 or less hypertension-directed medications.
Exclusion Criteria:
- 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.
- Have a medical history of clinically significant gastric emptying abnormality (for example, severe gastroparesis or gastric outlet obstruction), chronically take drugs that directly affect gastrointestinal (GI) motility, or have a history of any clinically relevant GI diseases or symptoms of GI disorders potentially affecting interpretation of study data.
- Have a history of hypocalcemia or ionized serum calcium below the normal range at Screening and Day -2 eligibility confirmation.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Sperimentale: Arm 1, SAD: VRB-103 or VRB-101 or Placebo
Each participant will receive a single oral dose of VRB-103 alone, VRB-103 co-administered with VRB-101, or placebo once.
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Le compresse VRB-101 saranno somministrate per via orale.
Altri nomi:
VRB-103 tablets will be administered orally.
Placebo tablets will be administered orally.
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Sperimentale: Arm 2, MAD: VRB-103 or VRB-101 or Placebo
Each participant will receive oral doses of VRB-103 alone, VRB-101 alone, VRB-103 co-administered with VRB-101, or placebo, once weekly or once daily.
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Le compresse VRB-101 saranno somministrate per via orale.
Altri nomi:
VRB-103 tablets will be administered orally.
Placebo tablets will be administered orally.
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Sperimentale: Arm 3, MAD: VRB-103 or VRB-101 or Placebo
Each participant will receive oral doses of VRB-103 alone, VRB-101 alone, VRB-103 co-administered with VRB-101, or placebo, once weekly.
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Le compresse VRB-101 saranno somministrate per via orale.
Altri nomi:
VRB-103 tablets will be administered orally.
Placebo tablets will be administered orally.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Lasso di tempo: Screening up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
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Any clinically significant changes in lab parameters, hematology, ECG parameters, will be reported as TEAEs.
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Screening up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
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Number of Participants with Adverse Events of Special Interest (AESIs)
Lasso di tempo: Screening up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
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Screening up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
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Change in Columbia-Suicide Severity Rating Scale (C-SSRS) from Baseline
Lasso di tempo: Screening up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
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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.
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Screening up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
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Change in Patient Health Questionnaire-9 (PHQ-9) Scores from Baseline
Lasso di tempo: Screening up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
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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.
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Screening up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Plasma concentrations of VRB-103 and VRB-101
Lasso di tempo: Baseline up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
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Baseline up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
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Maximum Observed Plasma Concentration (Cmax) for VRB-103 and VRB-101
Lasso di tempo: Baseline up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
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Baseline up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
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Time to Reach Cmax (Tmax) for VRB-103 and VRB-101
Lasso di tempo: Baseline up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
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Baseline up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
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Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUCinf) for VRB-103 and VRB-101
Lasso di tempo: Arm 1: From Baseline up to Day 29
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Arm 1: From Baseline up to Day 29
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Half-life (t1/2) for VRB-103 and VRB-101
Lasso di tempo: Baseline up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
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Baseline up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
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Trough Concentration (Ctrough) of VRB-103 and VRB-101
Lasso di tempo: Baseline up to End of Study (Arm 2: Week 10 and Arm 3: Week 20)
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Baseline up to End of Study (Arm 2: Week 10 and Arm 3: Week 20)
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AUC Over the Dosing Interval (AUCtau) of VRB-103 and VRB-101
Lasso di tempo: Baseline up to End of Study (Arm 2: Week 10 and Arm 3: Week 20)
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Baseline up to End of Study (Arm 2: Week 10 and Arm 3: Week 20)
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Collaboratori e investigatori
Sponsor
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- VRB-103-101
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Informazioni su farmaci e dispositivi, documenti di studio
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