A Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03235050
• Date of registration: 21/07/2017
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: A Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes
• Scientific title: A Phase IIb, Randomised, Parallel, Double-Blind Placebo-Controlled and Open-Label Active Comparator Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes Mellitus
• Date of first enrolment: August 2, 2017
• Target sample size: 834
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03235050
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

Bulgaria, Canada, Czechia, Germany, Hungary, Mexico, Russian Federation, Slovakia, United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Provision of informed consent

- Male and female subjects aged = 18 years at screening

- Body mass index = 25 kg/m2 at screening

- HbA1c range of 7.0% to 10.5% (inclusive) at screening

- Diagnosed with type-2 diabetes mellitus (T2DM) and treated with metformin (stable dose
of =1500 mg/day or maximal tolerated dose) for at least 2 months prior to screening.
Use of another glucose-lowering medication for up to 2 weeks in the 2 months prior to
screening is acceptable

- Women of childbearing potential (WOCBP), not breastfeeding and using appropriate birth
control to avoid pregnancy throughout the study and for up to 4 weeks after the last
dose of investigational product (IP), with a negative pregnancy test within 72 hours
prior to the start of IP

Exclusion Criteria:

- History of, or any existing condition that, in the opinion of the Investigator, would
interfere with evaluation of the IP, put the subject at risk, influence the subject's
ability to participate or affect the interpretation of the results of the study and/or
any subject unable or unwilling to follow study procedures

- Any subject who has received another IP as part of a clinical study or a GLP-1
receptor agonist containing preparation within the last 30 days or 5 half lives of the
drug (whichever is longer) at the time of screening

- Severe allergy/hypersensitivity to any of the proposed study treatments or excipients

- Symptoms of acutely decompensated blood glucose control, a history of type 1 diabetes
mellitus or diabetic ketoacidosis, or if the subject has been treated with daily
subcutaneous (SC) insulin for a period longer than 2 weeks within 90 days prior to
screening

- Acute or chronic pancreatitis. Subjects with serum triglyceride concentrations above
1000 mg/dL (11 mmol/L) at screening

- Significant inflammatory bowel disease or other severe disease or surgery affecting
the upper Gastrointestinal (GI) tract

- Significant hepatic disease

- Impaired renal function defined as estimated glomerular filtration rate (eGFR) =30
mL/minute/1.73m2 at screening

- Severely uncontrolled hypertension

- Unstable angina pectoris, myocardial infarction (MI), transient ischaemic attack
(TIA), or stroke within 3 months prior to screening

- Severe congestive heart failure



Age minimum: 18 Years
Age maximum: 130 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Intervention(s)

Drug: MEDI0382 high dose

Drug: MEDI0382 low dose

Drug: Placebo

Drug: MEDI0382 mid dose

Drug: Liraglutide

Primary Outcome(s)

Percent Change in Body Weight [Time Frame: From baseline to 14 weeks]

Change in HbA1c [Time Frame: From baseline to 14 weeks]

Secondary Outcome(s)

Absolute Change in Body Weight [Time Frame: from baseline to 14 weeks, 26 weeks and 54 weeks]

Percentage of Participants Achieving an HbA1c Target < 7.0% [Time Frame: after 14, 26, and 54 weeks]

Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control [Time Frame: at 14 weeks, 26 weeks and 54 weeks]

Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) [Time Frame: Time points at which outcome measure were assessed for plasma concentration were Weeks 1,2,6,10,14,18,22,26, and 54]

Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants [Time Frame: Baseline through 54-week treatment period and 28-day follow-up]

Percentage of Participants Achieving Weight Loss of =5% and =10% [Time Frame: after 14 weeks, 26 weeks and 54 weeks]

Absolute Change in Body Weight Versus Active Comparator [Time Frame: from baseline to 14 weeks, 26 weeks and 54 weeks]

Change in HbA1c [Time Frame: from baseline to 26 weeks and 54 weeks]

Percent Change in Body Weight [Time Frame: from baseline to 26 weeks and 54 weeks]

Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants) [Time Frame: Baseline through 54-week treatment period and 28-day follow-up]

Percent Change in Body Weight Versus Active Comparator [Time Frame: from baseline to 14 weeks, 26 weeks and 54 weeks]

Secondary ID(s)

D5670C00004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

MedImmune LLC

Results

• Results available: Yes
• Date Posted: 20/07/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03235050