Phase 2
Completed N=28
A Study to Evaluate the Effect of MEDI0382 on Energy Balance in Overweight and Obese Participants With Type 2 Diabetes Mellitus
Diabetes Mellitus, Type II · Obesity
Source: ClinicalTrials.gov NCT03596177 ↗
Enrolled (actual)
28
Serious AEs
8.0%
Results posted
Jan 2021
Primary outcomePrimary: Percent Change in Body Weight From Baseline to Day 59 — -1.40; -3.98 Percent change in body weight — p=0.011
Summary
An exploratory study to evaluate the effect of MEDI0382 on energy balance in overweight and obese participants with type 2 diabetes mellitus
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Body Weight From Baseline to Day 59 |
-1.40; -3.98 | 0.011 sig |
| SECONDARY Percent Change in Total Energy Intake From the ad Libitum Lunch From Baseline to Day 32 and Day 59 |
-5.170; -50.652; -10.598; -51.922 | 0.002 sig |
| SECONDARY Change in Total Energy Intake From the ad Libitum Lunch From Baseline to Day 32 and Day 59 |
-126.271; -1677.465; -410.816; -1743.331 | <0.001 sig |
| SECONDARY Percent Change in Total Energy Expenditure (TEE) as Measured by Whole Room Indirect Calorimetry From Baseline to Day 58 |
2.032; -1.141 | 0.384 |
| SECONDARY Change in TEE as Measured by Whole Room Indirect Calorimetry From Baseline to Day 58 |
5.969; -4.070 | 0.351 |
| SECONDARY Percent Change in Activity Energy Expenditure (AEE) as Measured by Whole Room Indirect Calorimetry From Baseline to Day 58 |
-0.446; -0.261 | 0.968 |
| SECONDARY Change in AEE as Measured by Whole Room Indirect Calorimetry From Baseline to Day 58 |
-1.132; -0.265 | 0.580 |
| SECONDARY Percent Change in Resting Energy Expenditure (REE) as Measured by Whole Room Indirect Calorimetry From Baseline to Day 58 |
8.113; 4.468 | 0.324 |
| SECONDARY Change in REE as Measured by Whole Room Indirect Calorimetry From Baseline to Day 58 |
13.237; 7.565 | 0.412 |
| SECONDARY Percent Change in REE as Measured by Hood Indirect Calorimetry From Baseline to Day 32 |
1.189; 8.546 | 0.177 |
| SECONDARY Change in REE as Measured by Hood Indirect Calorimetry From Baseline to Day 32 |
3.316; 18.502 | 0.168 |
| SECONDARY Change in Body Weight From Baseline to Day 59 |
-1.26; -3.80 | 0.009 sig |
| SECONDARY Percent Change in Total Body Fat Mass as Measured by Dual-energy X-ray Absorptiometry (DXA) From Baseline to Day 59 |
-4.218; -9.340 | 0.107 |
| SECONDARY Change in Total Body Fat Mass as Measured by DXA From Baseline to Day 59 |
-1.455; -3.303 | 0.085 |
| SECONDARY Percent Change in Total Body Fat Mass: Lean Mass Ratio as Measured by DXA From Baseline to Day 59 |
-1.667; -4.827 | 0.204 |
| SECONDARY Change in Total Body Fat Mass: Lean Mass Ratio as Measured by DXA From Baseline to Day 59 |
-0.010; -0.029 | 0.145 |
| SECONDARY Change in Fasting Glucose During a Mixed-meal Tolerance Test (MMTT) From Baseline to Day 59 |
-12.600; -38.601 | 0.001 sig |
| SECONDARY Percent Change in Glucose Area Under the Concentration-time Curve at 0 to 4 Hours (AUC0-4hrs) During a MMTT From Baseline to Day 59 |
-6.773; -19.105 | 0.010 sig |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) |
5; 17; 0; 2 | — |
| SECONDARY Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs |
0; 0 | — |
| SECONDARY Number of Participants With Abnormal Vital Signs Reported as TEAEs |
0; 0 | — |
| SECONDARY Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs |
0; 4 | — |
| SECONDARY Number of Participants With Positive Anti-drug Antibodies (ADAs) to MEDI0382 |
0; 3; 0; 0; 0; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Participants aged >= 30 and 28 and 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
Exclusion Criteria
- 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 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
- Impaired renal function defined as estimated glomerular filtration rate (eGFR) 180 mm Hg
- Diastolic BP or > 100 mm Hg After 10 minutes of supine rest and confirmed by repeated measurement at screening.
Participants who fail BP screening criteria may be considered for 24-hour ambulatory BP monitoring at the discretion of the investigator. Participants who maintain a mean 24-hour BP 15% will be considered eligible
- Unstable angina pectoris, myocardial infarction, transient ischemic attack or stroke within 3 months prior to screening, or participants who have undergone percutaneous coronary intervention or a coronary artery bypass graft within the past 6 months or who are due to undergo these procedures at the time of screening
- Severe congestive heart failure (New York Heart Associati
Data sourced from ClinicalTrials.gov (NCT03596177). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.