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

7 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

336

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

      • Melbourne, Australië
        • Werving
        • Nucleus Network

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
VRB-101-tabletten worden oraal toegediend.
Andere namen:
  • Oraal Ecnoglutide
VRB-103 tablets will be administered orally.
Placebo tablets will be administered orally.
Experimenteel: 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.
VRB-101-tabletten worden oraal toegediend.
Andere namen:
  • Oraal Ecnoglutide
VRB-103 tablets will be administered orally.
Placebo tablets will be administered orally.
Experimenteel: 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.
VRB-101-tabletten worden oraal toegediend.
Andere namen:
  • Oraal Ecnoglutide
VRB-103 tablets will be administered orally.
Placebo tablets will be administered orally.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Plasma concentrations of VRB-103 and VRB-101
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

6 juli 2026

Primaire voltooiing (Geschat)

1 maart 2028

Studie voltooiing (Geschat)

1 maart 2028

Studieregistratiedata

Eerst ingediend

29 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

29 mei 2026

Eerst geplaatst (Werkelijk)

4 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

7 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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