ObesityPhase 1NCT07628127
A Trial of Oral VRB-103 Alone or in Combination With Oral Ecnoglutide (VRB-101) in Participants With Obesity or Overweight
A Phase 1 study testing VRB-103 and VRB-101 in people with Obesity and Overweight, run by Verdiva Bio Dev Limited at 3 sites in Australia.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- VRB-103 and VRB-101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 332 participants
- Where
- 3 sitesAustralia
- Study dates
- 6 Jul 2026to Mar 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 (Arm 1) OR
- ≥27 kg/m^2 and ≤40.0 kg/m^2 (Arm 2 and Arm 3)
- Weight ≥70 kg with self-reported stable body weight (≤5% body weight change) for the 3 months prior to randomization.
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- 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 confirmation (an average of duplicate readings) with 2 or less hypertension-directed medications.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Verdiva Bio Medical Affairs contact
Australia3 sites, 3 recruiting
- Recruiting
Nucleus Network
Brisbane
- Recruiting
Nucleus Network
Melbourne
- Recruiting
Veritus
Melbourne
About this study
Official title: 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.
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.
- Conditions
- Obesity, Overweight
- Being tested
- VRB-103, Placebo, VRB-101
- Keywords
- Glucagon-like peptide-1 (GLP-1), Recombinant human amylin analog
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRB-103Drug
VRB-103 tablets will be administered orally.
PlaceboOther
Placebo tablets will be administered orally.
VRB-101Drug
Also called Oral Ecnoglutide
VRB-101 tablets will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1, SAD | Experimental | Each participant will receive a single oral dose of VRB-103 alone, VRB-103 co-administered with VRB-101, or placebo once. Receives: Drug: VRB-103; Other: Placebo; Drug: VRB-101 |
| Arm 2, MAD | Experimental | Each participant will receive multiple oral doses of VRB-103 or placebo. Receives: Drug: VRB-103; Other: Placebo |
| Arm 3, MAD | Experimental | Each participant will receive multiple oral doses of VRB-103 alone, VRB-101 alone, VRB-103 co-administered with VRB-101, or placebo. Receives: Drug: VRB-103; Other: Placebo; Drug: VRB-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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
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.
Measured: Screening up to Day 8 (Arm 1) or End of Treatment (Arm 2: Week 7 and Arm 3: Week 17)
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.
Measured: Screening up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)
Secondary outcomes (7)
Plasma concentrations of VRB-103 and VRB-101
Measured: 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
Measured: 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
Measured: 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
Measured: Arm 1: From Baseline up to Day 29
Half-life (t1/2) for VRB-103 and VRB-101
Measured: 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
Measured: 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
Measured: Baseline up to End of Study (Arm 2: Week 10 and Arm 3: Week 20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start6 Jul 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Verdiva Bio Dev Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07628127
- Sponsor's protocol ID
- VRB-103-101
- Status last verified
- Aug 2026
- First submitted
- 29 May 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No