NCT03335371

Evaluation of TTP399 in Patients With Type 1 Diabetes

A Multi-Center, Randomized, Double-Blind, Parallel-Group, Multiple-Dose, Adaptive Study Assessing the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of TTP399 in With Adult Patients Type 1 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: vTv Therapeutics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of TTP399 in Type 1 diabetics. This study will be in 2 phases: phase 1 will evaluate the safety of different TTP399 dosage regimens over 1 week of daily dosing. Phase 2 will evaluate the safety and efficacy of a TTP399 dosing regimen over 12 weeks of daily dosing.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	TTP399	Phase 1: Participants will receive TTP399 administered orally up to 1200 mg taken once daily for 7 days
DRUG	TTP399	Phase 2: Participants will receive TTP399 administered orally 800 mg taken once daily for 12 weeks
DRUG	Placebo Oral Tablet	Phase 2: Participants will receive Placebo oral tablets for 12 weeks

Timeline

• Start date: 2017-10-25
• Primary completion: 2019-12-20
• Completion: 2020-01-06
• First posted: 2017-11-07
• Last updated: 2023-07-03
• Results posted: 2023-07-03

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study