NCT05248776

Efficacy, Safety and Pharmacokinetics Study of CPL207280 After 2-weeks Administration in Subjects With Type 2 Diabetes

A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety and Pharmacokinetics After 2-weeks Administration of CPL207280 (GPR40 Agonist) in Subjects With Type 2 Diabetes (T2D)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Celon Pharma SA · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The planned study is to evaluate the efficacy, safety and pharmacokinetic (PK) properties of CPL207280 after multiple (14 days) administration in patients with type 2 diabetes.

Detailed description

A double-blind, randomized, placebo-controlled, parallel-group study of 4 different doses of CPL207280 administered orally for 14 days. Approximately 80 participants will be randomized at a 1:1:1:1:1 ratio to 5 arms to receive Investigational Medicinal Product (IMP) or placebo.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	CPL207280	IMP is a tablet with CPL207280 as an Active Pharmaceutical Ingredient (API).
DRUG	Placebo	Matching placebo tablet.

Timeline

• Start date: 2022-01-21
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2022-02-21
• Last updated: 2023-02-08

Locations

1 site across 1 country: Poland