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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorVerdiva Bio Dev Limited

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • VRB-103

    Drug

    VRB-103 tablets will be administered orally.

  • Placebo

    Other intervention

    Placebo tablets will be administered orally.

  • VRB-101

    Drug

    VRB-101 tablets will be administered orally.

Treatment groups

332 Participants
are divided into 3 treatment groups
Group A: Arm 1, SADExperimental treatment 3 interventions
Group B: Arm 2, MADExperimental treatment 2 interventions
Group C: Arm 3, MADExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Screening up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
2

Number of Participants with Adverse Events of Special Interest (AESIs)

Time frame
Screening up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
3

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.

Time frame
Screening up to Day 8 (Arm 1) or End of Treatment (Arm 2: Week 7 and Arm 3: Week 17)
4

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.

Time frame
Screening up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)

Secondary outcomes

1

Plasma concentrations of VRB-103 and VRB-101

Time frame
Baseline up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
2

Maximum Observed Plasma Concentration (Cmax) for VRB-103 and VRB-101

Time frame
Baseline up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
3

Time to Reach Cmax (Tmax) for VRB-103 and VRB-101

Time frame
Baseline up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
4

Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUCinf) for VRB-103 and VRB-101

Time frame
Arm 1: From Baseline up to Day 29

Other outcomes

Sponsors and contacts

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