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Phase 1Recruiting

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

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

Sponsor
Verdiva Bio Dev Limited (Industry)
Enrolment
332 planned
Conditions
Obesity; Overweight
Interventions
VRB-103; Placebo; VRB-101
Ages
adults
Registry
NCT07628127

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
  • Number of Participants with Adverse Events of Special Interest (AESIs)
  • Change in Columbia-Suicide Severity Rating Scale (C-SSRS) from Baseline
  • Change in Patient Health Questionnaire-9 (PHQ-9) Scores from Baseline

History

  1. Primary completion expected

  2. Last registry update

  3. Started

  4. Registered