Clinical trial

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

Recruiting now · Phase 1 · 1 countries · Registry ID NCT07628127

Recruiting nowPhase 1Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 60 Years
SexAll
Healthy volunteersAccepted
ConditionObesity, Overweight

Full registry 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 (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.

Treatments and study arms

VRB-103

Drug

VRB-103 tablets will be administered orally.

Placebo

Other

Placebo tablets will be administered orally.

VRB-101

Drug

VRB-101 tablets will be administered orally.

Primary outcomes

Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)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.

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

Change in Patient Health Questionnaire-9 (PHQ-9) Scores from BaselineScreening 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Nucleus Network🇦🇺 Melbourne, Australia