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

Registration

Registration

NCT07628127

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

TRIPLE

Status

RECRUITING

Enrollment

332

Start

2026-07-06

Primary completion

2028-03

Lead sponsor

Verdiva Bio Dev Limited

Conditions

Obesity; Overweight

Interventions

DRUG:VRB-103; OTHER:Placebo; DRUG:VRB-101

Results posted

FALSE

Individual participant data sharing

NO

Registered 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)]
• 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 Baseline [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 [Screening up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)]