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Safety and Tolerability Study of MEDI0382 in Japanese Preobese or Obese Subjects With Type 2 Diabetes

NCT03645421 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2019-12-23

Study results available
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Summary

This is a Phase 2a study designed to assess the safety and tolerability of MEDI0382 titrated up to a dose level of 100, 200 or 300 µg from 50 µg vs Placebo across 48 days in Japanese subjects.

The study D5674C00001 can be conducted with a reasonable expectation of safety and tolerability in Japanese T2DM patients. The design of this study has taken into account the known benefits and risks of GLP-1 receptor agonists and glucagon receptor agonists as well as the translatable effects observed in nonclinical studies of MEDI0382.

Conditions

Interventions

DRUG

MEDI0382 100 μg

Solution for injection in 1.0 mL pre-filled syringe, 100 μg per dose, 1 dose

DRUG

MEDI0382 200 μg

Solution for injection in 1.0 mL pre filled syringe 200 μg per dose, 1 dose

DRUG

MEDI0382 300 μg

Solution for injection in 1.0 mL pre filled syringe, 300 μg per dose, 1 dose

DRUG

PlaceboA

1.0 mL liquid formulation per Vial

DRUG

MEDI0382 50 ug

Solution for injection, 1.0 mL per vial, 50 ug

DRUG

PlaceboB

Solution for injection in 1.0 mL pre-filled syringe.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-10
Primary Completion
2019-01-17
Completion
2019-01-17

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT03645421 on ClinicalTrials.gov