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

NCT03596177 | Completed Phase 2 Results

• 1 other identifier: D5670C00021
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus, Type II; Obesity

Keywords

Diabetes Mellitus, Type II; Obesity; MEDI0382

Outcome Measures

Primary Outcomes (1)

• Percent Change in Body Weight From Baseline to Day 59

  Percent change in body weight from baseline to Day 59 is reported. Day 17 was considered as baseline for this outcome measure. The last observation carried forward (LOCF) analysis was used for missing data imputation for Day 59.

  Baseline (Day 17) and Day 59

Secondary Outcomes (22)

• Percent Change in Total Energy Intake From the ad Libitum Lunch From Baseline to Day 32 and Day 59

  Baseline (Day 16), Day 32, and Day 59

• Change in Total Energy Intake From the ad Libitum Lunch From Baseline to Day 32 and Day 59

  Baseline (Day 16) to Day 32 and Day 59

• Percent Change in Total Energy Expenditure (TEE) as Measured by Whole Room Indirect Calorimetry From Baseline to Day 58

  Baseline (Day 15) and Day 58

• Change in TEE as Measured by Whole Room Indirect Calorimetry From Baseline to Day 58

  Baseline (Day 15) and Day 58

• Percent Change in Activity Energy Expenditure (AEE) as Measured by Whole Room Indirect Calorimetry From Baseline to Day 58

  Baseline (Day 15) and Day 58

Study Arms (2)

MEDI0382

EXPERIMENTAL

Participants will receive subcutaneous (SC) injection of placebo for 16 days in the single-blind treatment period, and then SC injection of MEDI0382 titrated up to 300 μg for 42 days (100 μg for 4 days, followed by 200 μg for 4 days, and finally 300 μg for 34 days) in double-blind treatment period.

Drug: MEDI0382; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Participants will receive SC injection of placebo for 16 days in the single-blind treatment period, and then SC injection of placebo matched to MEDI0382 for 42 days in double-blind treatment period.

Drug: Placebo

Interventions

MEDI0382 DRUG

MEDI0382 will be administered subcutaneously, titrated up to 300 μg for 42 days (100 μg for 4 days, followed by 200 μg for 4 days, and finally 300 μg for 34 days) in double-blind treatment period.

MEDI0382

Placebo DRUG

Placebo will be administered subcutaneously for 16 days in the single-blind treatment period in both MEDI0382 and placebo arms, and SC injection of placebo matched to MEDI0382 for 42 days in double-blind treatment period in placebo arm.

MEDI0382; Placebo

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants aged \>= 30 and \<= 75 years at screening
• 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
• Body Mass Index \> 28 and \<= 40 kg/m\^2 at screening
• Glycated haemoglobin (HbA1c) \<= 8.0% at screening
• 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.
• Female participants of childbearing potential must have a negative pregnancy test at screening and randomisation, and must not be lactating.
• 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

You may not qualify if:

• 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
• Any participant with a cardiac pacemaker or implanted/portable electronic device
• 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)
• 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)
• Concurrent participation in another study with a study drug and prior randomisation in this study is prohibited
• Severe allergy/hypersensitivity to any of the proposed study treatments, excipients, or standardised meals
• 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.
• 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
• Regularly engage in high intensity exercise at least three times per week or have done so in the prior three months
• 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
• Acute or chronic pancreatitis
• Significant hepatic disease (except for nonalcoholic steatohepatitis or nonalcoholic fatty liver disease without portal hypertension or cirrhosis) and/or participants with any of the following results at screening:
• Aspartate transaminase (AST) \>= 3 × upper limit of normal (ULN)
• Alanine transaminase (ALT) \>= 3 × ULN
• Total bilirubin \>= 2 × ULN

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (1)

Research Site

Cambridge, CB2 0QQ, United Kingdom

Location

Related Links

• D5670C00021 CSP redacted
• D5670C00021 SAP redacted
• CSR Addendum synopsis\_Redacted

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

cotadutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

For Participant Flow section, Pre-assignment details: Data not collected for Secondary Outcome Measures #24 and #25: * Percentage change in TEE as measured by doubly labelled water from baseline (Day 17) to End of Treatment (EOT; Day 58 or 59\], * Change in TEE as measured by doubly labelled water from baseline (Day 17) to End of Treatment (EOT; Day 58 or 59\]).

Results Point of Contact

• Title: Victoria Parker
• Organization: MedImmune, LLC

information.center@astrazeneca.com

+44 747 1357172

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised, Double-Blind, Placebo-Controlled

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: July 23, 2018
• Study Start: September 26, 2018
• Primary Completion: December 22, 2019
• Study Completion: December 22, 2019
• Last Updated: January 19, 2023
• Results First Posted: January 15, 2021

Record last verified: 2022-12

Locations

GB (1)