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RecruitingNCT07628127Updated Aug 11, 2026

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

A Phase 1 interventional study of VRB-103 and Placebo in Obesity and Overweight, sponsored by Verdiva Bio Dev Limited. Recruiting at 1 site in Australia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by Verdiva Bio Dev Limited · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
336
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Obesity
  • Overweight

Keywords

  • Glucagon-like peptide-1 (GLP-1)
  • Recombinant human amylin analog
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 336 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Verdiva Bio Dev Limited is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
336 participants (estimated)

Study arms

  • 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.

    Drug: VRB-103 · Other: Placebo · Drug: VRB-101

  • 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.

    Drug: VRB-103 · Other: Placebo · Drug: VRB-101

  • 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.

    Drug: VRB-103 · Other: Placebo · Drug: VRB-101

Interventions

  • DrugVRB-103

    VRB-103 tablets will be administered orally.

  • OtherPlacebo

    Placebo tablets will be administered orally.

  • DrugVRB-101

    VRB-101 tablets will be administered orally.

    Also known as: Oral Ecnoglutide

06

What researchers measure

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 End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)

  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

  5. Half-life (t1/2) 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)

  6. Trough Concentration (Ctrough) of VRB-103 and VRB-101

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

  7. AUC Over the Dosing Interval (AUCtau) of VRB-103 and VRB-101

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

07

Study locations

1 of 1 sites recruiting
  • Nucleus Network
    Melbourne, Australia
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07628127
Lead sponsor
Verdiva Bio Dev Limited
Responsible party
Sponsor
First posted
Jun 4, 2026
Start date
Jul 6, 2026
Primary completion
Mar 2028 (estimated)
Completion
Mar 2028 (estimated)
Last update
Aug 11, 2026

Study contacts

Verdiva Bio Medical Affairs
Contact
medical.affairs@verdivabio.com

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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