Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

A Trial of Oral VRB-103 Alone or in Combination With Oral Ecnoglutide (VRB-101) in Participants With Obesity or Overweight

7 de agosto de 2026 atualizado por: Verdiva Bio Dev Limited

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

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.

Visão geral do estudo

Status

Recrutamento

Descrição detalhada

For Arm 1 (single ascending dose [SAD] part), 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 to participants with elevated body mass index (BMI) (≥25 kg/m^2 and ≤35 kg/m^2) who are otherwise healthy. For Arm 2 and Arm 3 (multiple ascending dose [MAD] parts), the primary objective is to evaluate the safety and tolerability of multiple ascending doses of VRB-103 tablets administered as monotherapy, VRB-101 tablets administered as monotherapy, or VRB-103 tablets administered in combination with VRB-101 tablets to participants with elevated BMI (≥27 kg/m^2 and ≤40 kg/m^2) who are otherwise healthy.

Tipo de estudo

Intervencional

Inscrição (Estimado)

336

Estágio

  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

      • Melbourne, Austrália
        • Recrutamento
        • Nucleus Network

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Sim

Descrição

Inclusion Criteria:

  1. Male or female assigned at birth, inclusive of all gender identities.
  2. Have HbA1c ≤6.4% at Screening and Day -2 eligibility confirmation.
  3. Have a BMI of:

    1. ≥25 kg/m^2 and ≤35.0 kg/m^2 (Part A) OR
    2. ≥27 kg/m^2 and ≤40.0 kg/m^2 (Part B and Part C)
  4. Weight ≥70 kg with self-reported stable body weight (≤5% body weight change) for the 3 months prior to randomization.
  5. 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.
  6. 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.
  7. Persons of childbearing potential must be non-pregnant and non-lactating and must agree to use study-specified contraceptive methods.
  8. 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:

  1. 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.
  2. 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).
  3. 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.
  4. 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.
  5. 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.
  6. Have a history of hypocalcemia or ionized serum calcium below the normal range at Screening and Day -2 eligibility confirmation.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Os comprimidos VRB-101 serão administrados por via oral.
Outros nomes:
  • Ecnoglutide Oral
VRB-103 tablets will be administered orally.
Placebo tablets will be administered orally.
Experimental: 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.
Os comprimidos VRB-101 serão administrados por via oral.
Outros nomes:
  • Ecnoglutide Oral
VRB-103 tablets will be administered orally.
Placebo tablets will be administered orally.
Experimental: 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.
Os comprimidos VRB-101 serão administrados por via oral.
Outros nomes:
  • Ecnoglutide Oral
VRB-103 tablets will be administered orally.
Placebo tablets will be administered orally.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Prazo: Screening up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
Any clinically significant changes in lab parameters, hematology, ECG parameters, will be reported as TEAEs.
Screening up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
Number of Participants with Adverse Events of Special Interest (AESIs)
Prazo: Screening up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
Screening up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) from Baseline
Prazo: Screening up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
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.
Screening up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
Change in Patient Health Questionnaire-9 (PHQ-9) Scores from Baseline
Prazo: Screening up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
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.
Screening up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)

Medidas de resultados secundários

Medida de resultado
Prazo
Plasma concentrations of VRB-103 and VRB-101
Prazo: Baseline up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
Baseline up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
Maximum Observed Plasma Concentration (Cmax) for VRB-103 and VRB-101
Prazo: Baseline up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
Baseline up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
Time to Reach Cmax (Tmax) for VRB-103 and VRB-101
Prazo: Baseline up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
Baseline up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUCinf) for VRB-103 and VRB-101
Prazo: Arm 1: From Baseline up to Day 29
Arm 1: From Baseline up to Day 29
Half-life (t1/2) for VRB-103 and VRB-101
Prazo: Baseline up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
Baseline up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
Trough Concentration (Ctrough) of VRB-103 and VRB-101
Prazo: Baseline up to End of Study (Arm 2: Week 10 and Arm 3: Week 20)
Baseline up to End of Study (Arm 2: Week 10 and Arm 3: Week 20)
AUC Over the Dosing Interval (AUCtau) of VRB-103 and VRB-101
Prazo: Baseline up to End of Study (Arm 2: Week 10 and Arm 3: Week 20)
Baseline up to End of Study (Arm 2: Week 10 and Arm 3: Week 20)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

6 de julho de 2026

Conclusão Primária (Estimado)

1 de março de 2028

Conclusão do estudo (Estimado)

1 de março de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

29 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de maio de 2026

Primeira postagem (Real)

4 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever