Home › Trials › NCT07628127
Clinical trial Recruiting at 3 sites Phase 1 Interventional Ages 18 to 60

Oral VRB-103 Alone or With VRB-101 for Obesity/Overweight

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

Run by Verdiva Bio Dev Limited · NCT07628127 · Data updated 2026-11-12

This study tests whether oral VRB-103, alone or with VRB-101, is safe and tolerable in adults who are overweight or obese.

More Obesity trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 60 Years
SexAll
Enrollment332 (estimated)
SponsorVerdiva Bio Dev Limited
Industry-sponsored
Locations3 sites (Brisbane and 2 other locations)
StatusRecruiting
StartedJuly 6, 2026
Main results expectedMarch 2028
Study endsMarch 2028
Registry record updatedOctober 13, 2026
Trial IDNCT07628127 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with BMI 25–35 kg/m^2 (Arm 1) or 27–40 kg/m^2 (Arms 2 and 3), weight ≥70 kg, HbA1c ≤6.4%, and no active significant illnesses.

Probably not a fit

Participants with conditions affecting safety or with uncontrolled illness may not benefit and could be excluded.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial evaluates the safety and tolerability of VRB-103 tablets, given alone or in combination with VRB-101 tablets, in single-dose and multiple-dose regimens. Participants are generally healthy adults with BMI in specified ranges and HbA1c ≤6.4%, to explore dose-related safety signals. The study includes three arms: a single-ascending-dose arm and two multiple-ascending-dose arms, with evaluations of adverse events, vital signs, labs, and ECGs. Interventions include VRB-103, VRB-101, and placebo, with the aim of informing future efficacy studies in obesity or overweight populations.

Why it matters

Potential benefit: If successful, participants could gain access to a potentially safer or more tolerable option for weight management.

How similar studies have gone: Prior GLP-1 related weight-management approaches have shown safety signals in early-phase trials, but this exact combination and regimen is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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 (Arm 1) OR
   2. ≥27 kg/m\^2 and ≤40.0 kg/m\^2 (Arm 2 and Arm 3)
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 confirmation (an average of duplicate readings) 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.

Where it's running

  • Nucleus Network
    Brisbane, Australia     Recruiting
  • Nucleus Network
    Melbourne, Australia     Recruiting
  • Veritus
    Melbourne, Australia     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
Browse more
Obesity 1426Overweight 159
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.