NCT05113771

A Biomarker-Guided, Randomized, Placebo-Controlled Efficacy and Safety Study of Liafensine in Patients With TRD

A Biomarker-Guided, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Liafensine in Patients With Treatment-Resistant Depression

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: Denovo Biopharma LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study was conducted as a randomized, double-blind, placebo-controlled, multi-center Phase 2b study. Approximately 180 subjects with treatment resistant depression who meet all eligibility criteria will be enrolled. The primary endpoint is to demonstrate liafensine is superior to placebo in DGM4 positive patients with TRD.

Detailed description

This study is a randomized, double blind, placebo-controlled Phase 2b study to assess the efficacy, safety, tolerability, and pharmacokinetics of liafensine. Eligible patients were randomized 1:1:1 to receive liafensine 1 mg QD, liafensine 2 mg QD, or placebo QD. The main objectives of this study are as follows: Primary Efficacy Objective: To demonstrate that liafensine was superior to placebo in DGM4 positive patients with TRD as assessed by the change in MADRS total score from baseline to Day 42 of double blind treatment Key Secondary Efficacy Objective: To evaluate the change from baseline to Day 42 in DGM4 positive patients with TRD treated with liafensine vs placebo on the Clinical Global Impression-Severity Scale (CGI S) Other Secondary Efficacy Objective: To evaluate the Clinical Global Impression-Improvement Scale (CGI I) at Day 42 in DGM4 positive patients with TRD treated with liafensine vs placebo Safety Objective: To compare the safety and tolerability of liafensine vs placebo in all randomized patients with TRD who received at least one dose of study drug during double blind treatment Psychiatric assessments were performed by a psychiatrist or trained and certified clinical staff member. Neurologic assessments were performed by an experienced clinician. Patients who fulfilled Hy's Law, defined as ALT or AST ≥ 3 × ULN and TBL ≥ 2 × ULN, in the absence of significant increase in ALP and in the absence of an alternative diagnosis that explained the increase in total bilirubin, were discontinued, with medical follow up as appropriate.

Conditions

• Treatment Resistant Depression

Interventions

Type	Name	Description
DRUG	Liafensine	Liafensine
DRUG	Placebo	Placebo

Timeline

• Start date: 2022-06-29
• Primary completion: 2024-02-06
• Completion: 2024-03-05
• First posted: 2021-11-09
• Last updated: 2025-05-15
• Results posted: 2025-05-15

Locations

45 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study