A Phase 1 and 2 study of multiple increasing doses to evaluate the ability of MEDI0382 to produce the intended result and the safety of effects of MEDI0382 in overweight and obese subjects with Type 2 Diabetes.

A Phase 1/2, Randomized, Double-blind, Placebo-controlled, Multiple-ascending-dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MEDI0382 in Overweight and Obese Subjects with a History of Type 2 Diabetes Mellitus

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003716-36-DE

Enrollment

107

Registered

2014-12-08

Start date

2015-03-30

Completion date

Unknown

Last updated

2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes in Overweight and Obese Patients MedDRA version: 19.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Product Code: MEDI0382 Pharmaceutical Form: Solution for injection Current Sponsor code: MEDI0382 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2- P

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Male or female age 18-65 -Must provide written informed consent -Body mass index 27 to 40 kg/m2 -Vital signs within normal specified ranges -Diagnosis of T2DM and glucose control managed with metformin monotherapy where no significant dose change has occurred in the 3 months prior to screening. -Venous access suitable for multiple cannulations. -For subjects in Cohort 4, 5 and 6: Willing and able to self-administer daily SC injections. -Females must be non-lactating and non-childbearing potential -Males must practice 2 effective contraceptive measures if sexually active Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7

Exclusion criteria

Exclusion criteria: -Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product -History or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs -History of cancer within the last 10 years, with the exception of non-melanoma skin cancer -History or presence of diabetic foot ulcers -Any clinically important illness (apart from T2DM for subjects with known diabetes), medical/ surgical procedure, or trauma within 4 weeks prior to Day 1 dosing. -Symptoms of insulinopenia or poor blood glucose control - Fasting blood glucose = 200 mg/dL -Positive Hepatitis B, Hepatitis C or HIV test or use of antiretroviral medications at screening. -Use of any medicinal products or herbal preparations licensed for control of body weight or appetite is prohibited. -Known or suspected history of alcohol or drug abuse within the past 3 years. Positive drug screen.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to assess the effect of MEDI0382 on glucose control and body weight from baseline to the end of a 4-week treatment period at a stable dose (end of treatment).;Secondary Objective: Secondary Objectives: 1. To assess the effect of MEDI0382 on glucose control as measured by the standardized Mixed Meal Test (MMT), HbA1c, and fructosamine data from baseline through end of treatment 2. To characterize the safety profile of MEDI0382 following subcutaneous (SC) administration of multiple-ascending doses (MADs) 3. To characterize the pharmacokinetics (PK) and immunogenicity (IM) of MEDI0382 4. To characterize the pharmacodynamics (PD) effect of MEDI0382 on glucose metabolism following a MMT;Primary end point(s): Primary Endpoints (Cohort 4 only): • Change from baseline in glucose AUC (up to 240 minutes post-MMT) to end of treatment • Change from baseline in body weight in kg to end of treatment;Timepoint(s) of evaluation of this end point: End of Treatment	—

Measure

Time frame

Main Objective: The primary objective of this study is to assess the effect of MEDI0382 on glucose control and body weight from baseline to the end of a 4-week treatment period at a stable dose (end of treatment).;Secondary Objective: Secondary Objectives: 1. To assess the effect of MEDI0382 on glucose control as measured by the standardized Mixed Meal Test (MMT), HbA1c, and fructosamine data from baseline through end of treatment 2. To characterize the safety profile of MEDI0382 following subcutaneous (SC) administration of multiple-ascending doses (MADs) 3. To characterize the pharmacokinetics (PK) and immunogenicity (IM) of MEDI0382 4. To characterize the pharmacodynamics (PD) effect of MEDI0382 on glucose metabolism following a MMT;Primary end point(s): Primary Endpoints (Cohort 4 only): • Change from baseline in glucose AUC (up to 240 minutes post-MMT) to end of treatment • Change from baseline in body weight in kg to end of treatment;Timepoint(s) of evaluation of this end point: End of Treatment

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Secondary

Measure	Time frame
Secondary end point(s): Secondary Endpoints: • Change from baseline in HbA1c and fructosamine and percent change in 24-hour glucose AUC post-MMT through end of treatment • Percent change from baseline in MMT glucose AUC (up to 240 minutes post-MMT) to end of treatment • Change from baseline in body weight in kg to end of treatment • Adverse events (AEs) • Blood Pressure (BP) • Pulse • Safety laboratory test results • ECG findings • Columbia-Suicide Severity Rating Scale score (cohort 4) • PK endpoints for MEDI0382: AUC over a dosing duration, maximum observed concentration (Cmax), minimum observed concentration, time to maximum observed concentration (Tmax)(all cohorts); terminal half-life, and accumulation ratio (Cohorts 1 to 3 only) • Concentration of Metformin • Development of antidrug antibody (ADA) and titer (if positive) • PD endpoints (glucose metabolism panel): ? Glucose ? Beta cell health: insulin, pro-insulin, and c-peptide ? Incretins: GLP-1, glucagon, gastric inhibitory peptide (GIP) ? Cohorts 5 and 6 insulin and glucose only;Timepoint(s) of evaluation of this end point: Last study visit- Follow up, 28 days post last study visit.	—

Measure

Time frame

Secondary end point(s): Secondary Endpoints: • Change from baseline in HbA1c and fructosamine and percent change in 24-hour glucose AUC post-MMT through end of treatment • Percent change from baseline in MMT glucose AUC (up to 240 minutes post-MMT) to end of treatment • Change from baseline in body weight in kg to end of treatment • Adverse events (AEs) • Blood Pressure (BP) • Pulse • Safety laboratory test results • ECG findings • Columbia-Suicide Severity Rating Scale score (cohort 4) • PK endpoints for MEDI0382: AUC over a dosing duration, maximum observed concentration (Cmax), minimum observed concentration, time to maximum observed concentration (Tmax)(all cohorts); terminal half-life, and accumulation ratio (Cohorts 1 to 3 only) • Concentration of Metformin • Development of antidrug antibody (ADA) and titer (if positive) • PD endpoints (glucose metabolism panel): ? Glucose ? Beta cell health: insulin, pro-insulin, and c-peptide ? Incretins: GLP-1, glucagon, gastric inhibitory peptide (GIP) ? Cohorts 5 and 6 insulin and glucose only;Timepoint(s) of evaluation of this end point: Last study visit- Follow up, 28 days post last study visit.

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Countries

Germany

Contacts

Public ContactInformation Center

MedImmune LTD, a wholly owned subsidiary of AstraZeneca

information.center@astrazeneca.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026