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Evaluation of TTP399 in Patients With Type 1 Diabetes

NCT03335371 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2023-07-03

Study results available
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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

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

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • vTv Therapeutics

    lead INDUSTRY

Principal Investigators

  • Carmen Valcarce, Ph.D. · vTv Therapeutics, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-25
Primary Completion
2019-12-20
Completion
2020-01-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03335371 on ClinicalTrials.gov