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CompletedNCT03555994Updated Nov 12, 2024Results posted

A Study to Investigate the Effect of MEDI0382 on Hepatic Glycogen Metabolism in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.

A Phase 2 interventional study of MEDI0382 and Placebo in Type 2 Diabetes Mellitus, sponsored by MedImmune LLC. Completed at 3 sites in 3 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-11-12.

Sponsored by MedImmune LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study summary

A phase 2 study in two parts (A \& B) designed to evaluate the effect of MEDI0382 on Hepatic Glycogen Metabolism in subjects with Type 2 Diabetes Mellitus (T2DM). Approximately 20 subjects will be enrolled in Part A and approximately 30 subjects in Part B.

Read the detailed description

This is a 2-part exploratory Phase 2 study.

Part A is a randomised, double-blind, placebo-controlled study to evaluate the effect of MEDI0382 (also known as Cotadutide) administered once daily subcutaneously (SC) for 28 days on hepatic glycogen metabolism in overweight and obese subjects with T2DM. Part A is planned to randomise up to 20 subjects. Subjects from Part A will not be re-enrolled in Part B.

Part B is an exploratory Phase 2 randomised, double-blind, placebo-controlled and open-label active comparator study to evaluate the effect of MEDI0382 on hepatic glycogen metabolism in overweight and obese subjects with T2DM. Part B is planned to randomise approximately 30 subjects (not to exceed a maximum of 35 subjects). Subjects in Part B will be randomised to receive double-blind MEDI0382 or placebo, or open-label liraglutide once daily for 35 days.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • 0382, T2DM, Cotadutide, Overweight, Obese, MEDI0382
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 51 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

MedImmune LLC is the lead sponsor of 265 studies on the registry; none are open to participants now.

Of its 50 completed or terminated interventional studies of FDA-regulated products, 28 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Body mass index (BMI) ≥ 27 and ≤ 40 kg/m2 (inclusive) at screening
  • Glycated haemoglobin (HbA1c) ≤ 8.0% at screening
  • Diagnosed with T2DM with glucose control managed with metformin monotherapy where no significant dose change (increase or decrease ≥ 500 mg/day) has occurred in the 3 months prior to screening

Exclusion criteria

Exclusion criteria:

  • Any subject who has received another investigational product as part of a clinical study or a 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

  • Any subject who has received any of the following medications prior to the start of the study:

    • 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
    • Glucagon
    • Warfarin
  • Any contraindication to magnetic resonance imaging/MRS scanning including claustrophobia or dislike of confined spaces
  • Symptoms of acutely decompensated blood glucose control (eg, thirst, polyuria, weight loss), a history of type 1 diabetes mellitus (T1DM) or diabetic ketoacidosis, or if the subject has been treated with daily SC insulin within 90 days prior to screening
  • Recurrent unexplained hypoglycaemic episodes (defined as glucose \< 3.0 mmol/L or \< 54 mg/dL on more than 2 occasions in 6 months prior to screening)
  • Significant inflammatory bowel disease, gastroparesis, or other severe disease or surgery affecting the upper GI tract (including weightreducing 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 NASH or nonalcoholic fatty liver disease without portal hypertension or cirrhosis) and/or subjects 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) \< 30 mL/minute/1.73m2 at screening (glomerular filtration rate estimated according to Modification of Diet in Renal Disease (MDRD) using MDRD Study Equation IDMS-traceable (International System of Units [SI] units)

  • Poorly controlled hypertension defined as:

    • Systolic blood pressure (BP) > 180 mm Hg
    • Diastolic BP > 105 mm Hg After 10 minutes of supine rest and confirmed by repeated measurement at screening.
  • Unstable angina pectoris, myocardial infarction, transient ischemic attack or stroke within 3 months prior to screening, or subjects 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 Association Class III or IV)
  • Basal calcitonin level > 50 ng/L at screening or history/family history of medullary thyroid carcinoma or multiple endocrine neoplasia
  • History of neoplastic disease within 5 years prior to screening, except for adequately treated basal cell, squamous cell skin cancer, or in situ cervical cancer
  • Any positive results for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) antibody
  • Substance dependence or history of alcohol abuse and/or excess alcohol intake (defined as > 21 units per week for a male subject, and >14 units per week for a female subject). Subjects must have a negative alcohol test result at screening and prior to randomisation.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    MEDI0382 (Part A)

    MEDI0382 administered subcutaneously (Part A)

    Drug: MEDI0382

  • Placebo comparator
    Placebo (Part A)

    Placebo comparator administered subcutaneously (Part A)

    Drug: Placebo

  • Active comparator
    Liraglutide (Part B)

    Active comparator administered subcutaneously (Part B)

    Drug: Liraglutide

  • Experimental
    MEDI0382 (Part B)

    MEDI0382 administered subcutaneously (Part B)

    Drug: MEDI0382

  • Placebo comparator
    Placebo (Part B)

    Placebo comparator administered subcutaneously (Part B)

    Drug: Placebo

Interventions

  • DrugMEDI0382

    MEDI0382 administered subcutaneously

  • DrugPlacebo

    Placebo administered subcutaneously

  • DrugLiraglutide

    Liraglutide administered subcutaneously

06

What researchers measure

Primary outcomes

  1. Change in Hepatic Glycogen Concentration Adjusted for Liver Volume as Measured by MRS at T = 4 Hours Post Standardised Morning Meal From Baseline (Day -1) to the End of 28 Days of Treatment (Part A Only)

    To assess the effect of MEDI0382 on hepatic glycogen levels postprandially versus placebo after 28 days of treatment

    Time frame: Day -1 to Day 28

  2. Percentage Change in Fasting Hepatic Glycogen Concentration Adjusted for Liver Volume as Measured by MRS at T = 24 Hours Post Standardised Morning Meal From Baseline (Day -1) to the End of 35 Days of Treatment (Day 36) (Part B)

    To assess the effect of MEDI0382 on hepatic glycogen levels versus placebo after 35 days (Part B) of treatment

    Time frame: Day -1 to Day 36

Secondary outcomes

  1. Percentage Change in Fasting Hepatic Glycogen Concentration Adjusted for Liver Volume as Measured by MRS at T = 24 Hours Post Standardised Morning Meal From Baseline (Day 1) to the End of 35 Days of Treatment (Day 36, Part B Only)

    To assess the effect of MEDI0382 on hepatic glycogen levels versus liraglutide after 35 days of treatment (Part B only)

    Time frame: Fom baseline (Day -1) to Day 35

  2. Change of Hepatic Fat Fraction From Baseline as Measured by Magnetic Resonance Imaging (Day -1) to the End of 35 Days of Treatment (Part B Only)

    Time frame: Day -1 to Day 36

  3. Development of ADA

    Time frame: Baseline to (Follow-up Period) 28 days post last dose + (3-month poststudy)

  4. Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Number of Participants withTreatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE V4.0

    Safety and tolerability of daily SC doses of MEDI0382 by assessment of the following using CTCAE V4.0: The number of Treatment Emergent Adverse events (TEAEs)

    Time frame: Post dosing (Day 1) to final follow-up (28 Days post last dose)

  5. Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) as Assessed by CTCAE V4.0

    Safety and tolerability of daily SC doses of MEDI0382 by assessment of the following using CTCAE V4.0: The number of Treatment-Emergent Serious Adverse Events (TESAEs)

    Time frame: Post dosing (Day 1) to final follow-up (28 Days post last dose)

  6. Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Changes in Heart Rate and Blood Pressure

    Number of subjects with clinically significant changes in heart rate (BPM) or systolic and diastolic blood pressure (mmHg)

    Time frame: Post dosing (Day 1) to final follow-up (28 Days post last dose)

  7. Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Changes in ECG

    Number of subjects with an ECG determined to be abnormal and clinically significant

    Time frame: Post dosing (Day 1) to final follow-up (28 Days post last dose)

  8. Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Changes in Haematology and Clinical Chemistry Parameters

    Number of subjects with clinically significant changes in in haematology and or clinical chemistry parameters

    Time frame: Post dosing (Day 1) to final follow-up (28 Days post last dose)

07

Results

Posted Nov 12, 2024

Participant flow

In Part A, a total of 21 participants participated in the study from 31 May 2018 (date first participant enrolled for Part A) to 23 November 2018 (date of last participant last visit for Part A) at one site in Sweden. In Part B, a total of 30 participants participated in the study from 17 December 2019 (date first participant enrolled for Part B) to 14 April 2021 (date of last participant last visit for Part B) at 2 sites (one in Sweden and one in the Netherlands).

Participant flow — Overall Study
MilestonePlacebo (Part A)MEDI0382 (Part A)Liraglutide (Part B)MEDI0382 (Part B)Placebo (Part B)
Started91210911
Completed91010911
Not completed02000

Outcome measures

PrimaryChange in Hepatic Glycogen Concentration Adjusted for Liver Volume as Measured by MRS at T = 4 Hours Post Standardised Morning Meal From Baseline (Day -1) to the End of 28 Days of Treatment (Part A Only)

To assess the effect of MEDI0382 on hepatic glycogen levels postprandially versus placebo after 28 days of treatment

Time frame:
Day -1 to Day 28
Reported as:
Least squares mean · mmol/L
Change in Hepatic Glycogen Concentration Adjusted for Liver Volume as Measured by MRS at T = 4 Hours Post Standardised Morning Meal From Baseline (Day -1) to the End of 28 Days of Treatment (Part A Only)
mmol/LPlacebo (Part A)MEDI0382 (Part A)
Change in Hepatic Glycogen Concentration Adjusted for Liver Volume as Measured by MRS at T = 4 Hours Post Standardised Morning Meal From Baseline (Day -1) to the End of 28 Days of Treatment (Part A Only)5.5 (-47.2 to 58.3)-100.2 (-150.2 to -50.1)
Statistical analysis
  • Placebo (Part A) vs MEDI0382 (Part A) · ANCOVA · p = 0.023 · Least square mean difference: -105.7 · 90% CI -178.8 to -32.6
PrimaryPercentage Change in Fasting Hepatic Glycogen Concentration Adjusted for Liver Volume as Measured by MRS at T = 24 Hours Post Standardised Morning Meal From Baseline (Day -1) to the End of 35 Days of Treatment (Day 36) (Part B)

To assess the effect of MEDI0382 on hepatic glycogen levels versus placebo after 35 days (Part B) of treatment

Time frame:
Day -1 to Day 36
Reported as:
Least squares mean · percent change from baseline
Percentage Change in Fasting Hepatic Glycogen Concentration Adjusted for Liver Volume as Measured by MRS at T = 24 Hours Post Standardised Morning Meal From Baseline (Day -1) to the End of 35 Days of Treatment (Day 36) (Part B)
percent change from baselineMEDI0382 (Part B)Placebo (Part B)
Percentage Change in Fasting Hepatic Glycogen Concentration Adjusted for Liver Volume as Measured by MRS at T = 24 Hours Post Standardised Morning Meal From Baseline (Day -1) to the End of 35 Days of Treatment (Day 36) (Part B)-27.02 (-38.04 to -16.01)-1.15 (-11.09 to 8.79)
Statistical analysis
  • MEDI0382 (Part B) vs Placebo (Part B) · ANCOVA · p = 0.008 · Least square mean difference: -25.87 · 90% CI -40.88 to -10.86
SecondaryPercentage Change in Fasting Hepatic Glycogen Concentration Adjusted for Liver Volume as Measured by MRS at T = 24 Hours Post Standardised Morning Meal From Baseline (Day 1) to the End of 35 Days of Treatment (Day 36, Part B Only)

To assess the effect of MEDI0382 on hepatic glycogen levels versus liraglutide after 35 days of treatment (Part B only)

Time frame:
Fom baseline (Day -1) to Day 35
Reported as:
Least squares mean · percentage change from baseline
Percentage Change in Fasting Hepatic Glycogen Concentration Adjusted for Liver Volume as Measured by MRS at T = 24 Hours Post Standardised Morning Meal From Baseline (Day 1) to the End of 35 Days of Treatment (Day 36, Part B Only)
percentage change from baselineLiraglutideMEDI0382
Percentage Change in Fasting Hepatic Glycogen Concentration Adjusted for Liver Volume as Measured by MRS at T = 24 Hours Post Standardised Morning Meal From Baseline (Day 1) to the End of 35 Days of Treatment (Day 36, Part B Only)-5.33 (-13.97 to 3.32)-27.31 (-36.42 to -18.20)
Statistical analysis
  • Liraglutide vs MEDI0382 · ANCOVA · p = 0.008 · Least square mean difference: -21.99 · 90% CI -34.55 to -9.43
SecondaryChange of Hepatic Fat Fraction From Baseline as Measured by Magnetic Resonance Imaging (Day -1) to the End of 35 Days of Treatment (Part B Only)
Time frame:
Day -1 to Day 36
Reported as:
Least squares mean · percent
Change of Hepatic Fat Fraction From Baseline as Measured by Magnetic Resonance Imaging (Day -1) to the End of 35 Days of Treatment (Part B Only)
percentLiraglutide (Part B)MEDI0382 (Part B)Placebo (Part B)
Change of Hepatic Fat Fraction From Baseline as Measured by Magnetic Resonance Imaging (Day -1) to the End of 35 Days of Treatment (Part B Only)-15.40 (-21.09 to -9.72)-26.26 (-51.13 to -1.39)8.79 (-10.46 to 28.05)
Statistical analysis
  • MEDI0382 (Part B) vs Placebo (Part B) · ANCOVA · p = 0.070 · Least square mean difference: -35.06 · 90% CI -66.54 to -3.58
  • Liraglutide (Part B) vs MEDI0382 (Part B) · ANCOVA · p = 0.030 · Least square mean difference: -11.72 · 90% CI -20.13 to -3.30
SecondaryDevelopment of ADA
Time frame:
Baseline to (Follow-up Period) 28 days post last dose + (3-month poststudy)
Reported as:
Count of participants · Participants
Development of ADA
ParticipantsPlacebo (Part A)MEDI0382 (Part A)MEDI0382 (Part B)LiraglutidePlacebo (Part B)
Baseline ADA result00000
Day 28 ADA result for Part A Day 35 ADA result for Part B01300
Follow-up ADA result00300
Post Study ADA result00100
SecondaryMeasures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Number of Participants withTreatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE V4.0

Safety and tolerability of daily SC doses of MEDI0382 by assessment of the following using CTCAE V4.0: The number of Treatment Emergent Adverse events (TEAEs)

Time frame:
Post dosing (Day 1) to final follow-up (28 Days post last dose)
Reported as:
Count of participants · Participants
Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Number of Participants withTreatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE V4.0
ParticipantsPlacebo (Part A)MEDI0382 (Part A)Liraglutide (Part B)MEDI0382 (Part B)Placebo (Part B)
At least one event711876
At least one IP related event57773
SecondaryMeasures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) as Assessed by CTCAE V4.0

Safety and tolerability of daily SC doses of MEDI0382 by assessment of the following using CTCAE V4.0: The number of Treatment-Emergent Serious Adverse Events (TESAEs)

Time frame:
Post dosing (Day 1) to final follow-up (28 Days post last dose)
Reported as:
Count of participants · Participants
Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) as Assessed by CTCAE V4.0
ParticipantsPlacebo (Part A)MEDI0382 (Part A)Liraglutide (Part B)MEDI0382 (Part B)Placebo (Part B)
Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) as Assessed by CTCAE V4.000000
SecondaryMeasures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Changes in Heart Rate and Blood Pressure

Number of subjects with clinically significant changes in heart rate (BPM) or systolic and diastolic blood pressure (mmHg)

Time frame:
Post dosing (Day 1) to final follow-up (28 Days post last dose)
Reported as:
Count of participants · Participants
Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Changes in Heart Rate and Blood Pressure
ParticipantsPlacebo (Part A)MEDI0382 (Part A)Liraglutide (Part B)MEDI0382 (Part B)Placebo (Part B)
Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Changes in Heart Rate and Blood Pressure00000
SecondaryMeasures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Changes in ECG

Number of subjects with an ECG determined to be abnormal and clinically significant

Time frame:
Post dosing (Day 1) to final follow-up (28 Days post last dose)
Reported as:
Count of participants · Participants
Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Changes in ECG
ParticipantsPlacebo (Part A)MEDI0382 (Part A)Liraglutide (Part B)MEDI0382 (Part B)Placebo (Part B)
Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Changes in ECG00000
SecondaryMeasures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Changes in Haematology and Clinical Chemistry Parameters

Number of subjects with clinically significant changes in in haematology and or clinical chemistry parameters

Time frame:
Post dosing (Day 1) to final follow-up (28 Days post last dose)
Reported as:
Count of participants · Participants
Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Changes in Haematology and Clinical Chemistry Parameters
ParticipantsPlacebo (Part A)MEDI0382 (Part A)Liraglutide (Part B)MEDI0382 (Part B)Placebo (Part B)
Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Changes in Haematology and Clinical Chemistry Parameters00000

Adverse events

Collected over Post dosing (Day 1) to final follow-up (28 Days post last dose). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo (Part A)0/9 (0%)0/9 (0%)7/9 (77.8%)
MEDI0382 (Part A)0/12 (0%)0/12 (0%)11/12 (91.7%)
Liraglutide (Part B)0/10 (0%)0/10 (0%)8/10 (80%)
MEDI0382 (Part B)0/9 (0%)0/9 (0%)7/9 (77.8%)
Placebo (Part B)0/11 (0%)0/11 (0%)6/11 (54.5%)
Most frequent other events
Showing 10 of 56
Most frequent other events
EventPlacebo (Part A)MEDI0382 (Part A)Liraglutide (Part B)MEDI0382 (Part B)Placebo (Part B)
NauseaGastrointestinal disorders2/98/121/105/90/11
DyspepsiaGastrointestinal disorders2/96/121/100/90/11
FatigueGeneral disorders2/96/121/103/90/11
VomitingGastrointestinal disorders1/95/121/101/90/11
HeadacheNervous system disorders3/95/121/101/91/11
ConstipationGastrointestinal disorders0/93/122/102/90/11
Decreased appetiteMetabolism and nutrition disorders1/93/122/100/90/11
DizzinessNervous system disorders0/93/122/101/91/11
DiarrhoeaGastrointestinal disorders2/90/120/101/91/11
InsomniaPsychiatric disorders1/90/120/102/90/11

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Placebo (Part A)MEDI0382 (Part A)Liraglutide (Part B)MEDI0382 (Part B)Placebo (Part B)Total
Age69.3 ± 5.765.8 ± 7.365.2 ± 9.161.8 ± 7.564.0 ± 10.765.2 ± 8.2
Sex: Female, Male
Sex: Female, Male(Participants)Placebo (Part A)MEDI0382 (Part A)Liraglutide (Part B)MEDI0382 (Part B)Placebo (Part B)Total
Female3543217
Male6766934
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Placebo (Part A)MEDI0382 (Part A)Liraglutide (Part B)MEDI0382 (Part B)Placebo (Part B)Total
AMERICAN INDIAN OR ALASKA NATIVE000000
ASIAN000000
BLACK OR AFRICAN AMERICAN000000
OTHER000000
WHITE9121091151
08

Study locations

3 sites
  • Research Site
    Maastricht, 6229 ER, Netherlands
  • Research Site
    Uppsala, 752 37, Sweden
  • Research Site
    Nottingham, NG7 2UH, United Kingdom
09

References and documents

Study documents

  • Study protocol · Jul 15, 2020
  • Statistical analysis plan · May 31, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting information: Study protocol, Sap

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03555994
Lead sponsor
MedImmune LLC
Responsible party
Sponsor
First posted
Jun 14, 2018
Start date
May 31, 2018
Primary completion
Apr 14, 2021
Completion
Apr 14, 2021
Results posted
Nov 12, 2024
Last update
Nov 12, 2024

Study contacts

Folke Sjöberg, MD
principal investigator · CTC Clinical Trial Consultants AB
MacDonald
principal investigator · Nottingham
Schrauwen
principal investigator · Maastricht

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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