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MEDI0382 high dose

Phase 2

Non-alcoholic Fatty Liver Disease (NAFLD) | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Jan 17, 2023

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment74

FDA Designations

No designations recorded

Clinical trial landscape

MEDI0382 high dose · 1 trial · 2 indications

Phase 2 1
NCT04019561A Study to Evaluate Safety and Pharmacodynamic Efficacy of 0382 in Obese Subjects With NAFLD/NASH.Non-alcoholic Fatty Liver Disease (NAFLD)
COMPLETED74 Analytics
PHASE2COMPLETED
A Study to Evaluate Safety and Pharmacodynamic Efficacy of 0382 in Obese Subjects With NAFLD/NASH.
Non-alcoholic Fatty Liver Disease (NAFLD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Safety (Including Hepatic Safety) and Tolerability of MEDI0382 Compared With Placebo: Number of Participants With TEAE and SAE
Day 1 - Day 161

The number and percentage of treatment emergent adverse events (TEAE) and serious adverse events (SAE) through the end of the follow-up period

Secondary Endpoints

Immunogenicity Profile Defined by Presence of Anti-drug Antibodies (ADA): ADA Titer (if Confirmed Positive)
Day 1 - Day 161 (Baseline, Week 6, Week 12, Week 16, Week 19 and Week 23)
Immunogenicity Profile Defined by Presence of Anti-drug Antibodies (ADA): Number of Participants With Development of ADA
Day 1 - Day 161
Change From Baseline to Week 19 in Hepatic Fat Fraction (HFF)
Baseline to week 19
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MEDI0382 high doseEXPERIMENTALMEDI0382 high dose administered subcutaneously
Placebo for MEDI0382 high dosePLACEBO_COMPARATORPlacebo for MEDI0382 high dose administered subcutaneously
MEDI0382 low doseEXPERIMENTALMEDI0382 low dose administered subcutaneoously
Placebo for MEDI0382 low dosePLACEBO_COMPARATORPlacebo for MEDI0382 low dose administered subcutaneously

Interventions

NameTypeDescription
MEDI0382 high doseDRUGMEDI0382 high dose administered subcutaneously
Placebo for MEDI0382 high doseDRUGPlacebo for MEDI0382 high dose administered subcutaneously
MEDI0382 low doseDRUGMEDI0382 low dose administered subcutaneously
Placebo for MEDI0382 low doseDRUGPlacebo for MEDI0382 low dose administered subcutaneously
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Eligibility Criteria

Age Range18 Years to 101 Years
SexALL
Healthy VolunteersNo
Study Sites27

Inclusion Criteria: 1. Provision of informed consent (with the exception of consent for future genetic and non genetic research) prior to performing any study-specific procedures, including screening evaluations. 2. Subjects aged ≥ 18 years at the time of consent. 3. Body mass index ≥ 30 kg/m2 at s...

Countries:United StatesPuerto Rico
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Frequently asked questions about MEDI0382 high dose

What is MEDI0382 used for?

MEDI0382 is an investigational small molecule being developed for metabolic conditions, including obesity, type 2 diabetes mellitus, and non-alcoholic fatty liver disease (NAFLD). It has been studied in overweight and obese participants with type 2 diabetes. MEDI0382 is not approved and remains in clinical development.

Who makes MEDI0382?

MEDI0382 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical trials to evaluate the safety and efficacy of MEDI0382 in metabolic indications.

What phase is MEDI0382 in?

MEDI0382 is in Phase 2 clinical development. It has completed multiple Phase 2 trials, including studies in overweight and obese participants with type 2 diabetes. MEDI0382 is investigational and has not been approved by regulatory authorities.

What clinical trials is MEDI0382 in?

MEDI0382 has completed several clinical trials, including NCT02548585, a Phase 1 multiple-ascending-dose study, and NCT03244800, NCT03444584, and NCT03745937, which are Phase 2 studies. These trials evaluated MEDI0382 in overweight and obese participants with type 2 diabetes, including in combination with dapagliflozin and metformin.

Is MEDI0382 the same as 0382?

MEDI0382 is also referred to as 0382 in some clinical trial titles, such as NCT03244800, which investigates different doses of 0382. Both names refer to the same investigational drug being developed by AstraZeneca for metabolic conditions.