NCT06964230

A Phase 2b/3 Clinical Study Evaluating T3D-959 in Mild-to-Moderate Alzheimer's Disease Subjects

A Phase 2b/3 Randomized, Double-Blind, Placebo-Controlled Multi-Center Study to Evaluate the Safety and Efficacy of T3D-959 in Subjects With Mild-to-Moderate Alzheimer's Disease

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 376 (estimated)
• Sponsor: T3D Therapeutics, Inc. · Industry
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study is a Phase 2b/3 clinical trial of a new candidate drug (T3D-959) to treat patients with mild-to-moderate Alzheimer's. The aims of the trial are to affirm potential therapeutic efficacy and safety observed in earlier clinical trials and assess the potential to modify the course of disease. The drug will be compared to placebo and administered orally to patients once a day for 78 weeks.

Detailed description

This study is a randomized, double-blind, placebo-controlled study of T3D-959 30mg in subjects with clinical mild-to-moderate Alzheimer's Disease and a biological diagnosis of AD pathology, as defined by a validated plasma biomarker (presently %p-tau217 plasma biomarker). This study is designed as a seamless group sequential design where estimates of treatment effect on cognitive and functional scales will be evaluated in an interim analysis by independent statisticians. The sample size will be re-estimated to ensure the study is sufficiently powered to demonstrate efficacy of T3D-959 in cognition and function. Subjects will be assigned to one of two treatment arms (1:1 ratio) in a randomized, double-blind fashion, stratified by sex and ApoE4 genotype. Study medication will be taken once daily for 78 weeks. Safety/tolerability, efficacy and exploratory assessments will be evaluated for changes from baseline to end of treatment (78 weeks). Subjects will be followed for four weeks after the end of treatment.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	T3D-959	Experimental: T3D-959 30 mg dose: T3D-959 is a small molecule dual nuclear receptor agonist that regulates transcription of genes, in particular those involved in glucose energy and lipid metabolism. T3D-959 is 15-times more potent for PPAR delta than for the secondary target of the drug, PPAR gamma. The 15 mg strength capsules contain 15mg T3D-959, pregelatinized starch NF, magnesium stearate NF, and size 0, hard gelatin, white/white, opaque, unmarked capsules. Subjects will ingest two size 0, 15mg capsules once per day in the morning.
OTHER	Placebo Comparator	Placebo used to compare to T3D-959 drug

Timeline

• Start date: 2026-10-26
• Primary completion: 2031-04-01
• Completion: 2031-06-01
• First posted: 2025-05-09
• Last updated: 2025-05-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study