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A Study to Evaluate the Effect of MEDI0382 on Energy Balance in Overweight and Obese Participants With Type 2 Diabetes Mellitus | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study to Evaluate the Effect of MEDI0382 on Energy Balance in Overweight and Obese Participants With Type 2 Diabetes Mellitus

An Exploratory Phase 2a, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Effect of MEDI0382 on Energy Balance in Overweight and Obese Subjects With Type 2 Diabetes Mellitus

NCT03596177•MedImmune LLC

View on ClinicalTrials.gov

Summary

An exploratory study to evaluate the effect of MEDI0382 on energy balance in overweight and obese participants with type 2 diabetes mellitus

Detailed Description

An exploratory Phase 2a, randomised, double-blind, placebo-controlled study to evaluate the effect of MEDI0382 on energy balance in overweight and obese participants with type 2 diabetes mellitus

Eligibility

Age

30 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Participants aged \>= 30 and \<= 75 years at screening
•2. Provision of signed and dated written informed consent (except for consent for genetic and non-genetic research and additional optional assessments) prior to any protocol-related procedures
•3. Body Mass Index \> 28 and \<= 40 kg/m\^2 at screening
•4. Glycated haemoglobin (HbA1c) \<= 8.0% at screening
•5. Diagnosed with type 2 diabetes (T2DM) with glucose control managed with metformin, with or without a dipeptidyl peptidase 4 (DPPIV) inhibitor, Sodium-glucose co-transporter-2 inhibitors (SGLT2i), sulfonylurea, or meglitinide, where no significant dose change (increase or decrease \> 50%) has occurred in the 3 months prior to screening; if the participant is on dual therapy, a 4-week washout of the non-metformin therapy (DPPIV inhibitor, SGLT2i, sulfonylurea, or meglitinide) will be required prior to Visit 4.
•6. Female participants of childbearing potential must have a negative pregnancy test at screening and randomisation, and must not be lactating.
•7. Female participants of childbearing potential who are sexually active with a non-sterilised male partner must be using at least one highly effective method of contraception from screening and must agree to continue using such precautions up until 4 weeks after the last dose of study drug

Exclusion Criteria

•1. History of, or any existing condition(s) that, in the opinion of the investigator, would interfere with evaluation of the study drug, put the participant at risk, influence the participant's ability to participate or affect the interpretation of the results of the study and/or any participant unable or unwilling to follow study procedures
•2. Any participant with a cardiac pacemaker or implanted/portable electronic device
•3. Any participant who has received another study drug as part of a clinical study or a Glucagon-like peptide-1 (GLP-1) analogue-containing preparation within the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening (Visit 1)
•4. Any participant who has received any of the following medications within the specified timeframe prior to Visit 2: herbal preparations or drugs licensed for control of body weight or appetite (eg, orlistat, bupropion, naltrexone, phentermine-topiramate, phentermine, lorcaserin, opiates, domperidone, metoclopramide, or other drugs known to alter gastric emptying)
•5. Concurrent participation in another study with a study drug and prior randomisation in this study is prohibited
•6. Severe allergy/hypersensitivity to any of the proposed study treatments, excipients, or standardised meals
•7. Symptoms of acutely decompensated blood glucose control (eg, thirst, polyuria, weight loss), a history of type 1 diabetes mellitus or diabetic ketoacidosis, or if the participant has been treated with daily SC insulin within 90 days prior to screening.
•8. Abnormal thyroid stimulating hormone (TSH) level of \< 0.03 Milli-International Units Per Litre (mIU/L) or \> 10 mIU/L confirmed on two consecutive tests
•9. Regularly engage in high intensity exercise at least three times per week or have done so in the prior three months
•10. Clinically significant inflammatory bowel disease, gastroparesis or other severe disease or surgery affecting the upper gastrointestinal tract (including weight-reducing surgery and procedures) which may affect gastric emptying or could affect the interpretation of safety and tolerability data
+17 more criteria

Locations (1)

Research Site

Cambridge, United Kingdom

Key Dates

Start Date

September 26, 2018

Primary Completion Date

December 22, 2019

Completion Date

December 22, 2019

Last Updated

January 19, 2023

Enrollment

ACTUAL participants

Conditions

Diabetes Mellitus, Type IIObesity

Interventions

MEDI0382

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 19, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Effect of MEDI0382 on Energy Balance in Overweight and Obese Participants With Type 2 Diabetes Mellitus

Inclusion Criteria

Exclusion Criteria

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