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Type 2 DiabetesPhase 1NCT02524782

A Phase 1, Single- and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MEDI4166 in Subjects With Type 2 Diabetes

A Phase 1 study testing MEDI-4166 in people with Type 2 Diabetes, run by MedImmune LLC at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A Phase 1, combined Single Ascending Dose (SAD) and Multiple-ascending Dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MEDI4166 in Subjects with Type 2 Diabetes Mellitus (T2D). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
MEDI-4166
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
103 participants
Where
11 sitesUnited States
Study dates
7 Oct 2015to 14 Apr 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 2 Diabetes, ages 18-65
  • Must provide written informed consent
  • BMI>=25 and =<42
  • Venous access suitable for multiple cannulations
  • Vital signs within normal specified ranges
  • Females must be non-lactating and non-childbearing potential
  • Males must practice 2 effective contraceptive measures if sexually active

Who cannot join

  • Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
  • History or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
  • History of cancer, with the exception of basal cell carcinoma or carcinoma of the cervix
  • Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to dosing
  • Positive Hepatitis B, Hepatitis C or HIV test or use of antiretroviral medications at screening
  • Current or previous use of systemic corticosteroids within the past 28 days prior to screening
Show all 9Show fewer
  • Use of any medicinal products or herbal preparations licensed for weight loss is prohibited.
  • Positive drug screen
  • Type 1 diabetes

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Research Site

    Anniston, Alabama, 36207

  • Research Site

    Chula Vista, California, 91911

  • Research Site

    Cincinnati, Ohio, 45227

  • Research Site

    Durham, North Carolina, 27710

  • Research Site

    Jacksonville, Florida, 32216

  • Research Site

    Knoxville, Tennessee, 37920

  • Research Site

    Miami, Florida, 33014

  • Research Site

    Raleigh, North Carolina, 27612

  • Research Site

    San Antonio, Texas, 78209

  • Research Site

    San Antonio, Texas, 78229

  • Research Site

    South Miami, Florida, 33143

Other trials in United States

About this study

Official title: A Phase 1, Combined Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of MEDI4166 in Subjects With Type 2 Diabetes Mellitus (T2D)

A Phase 1, combined Single Ascending Dose (SAD) and Multiple-ascending Dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MEDI4166 in Subjects with Type 2 Diabetes Mellitus (T2D).

Read the detailed description

This study is a first time in human (FTIH), Phase 1, randomized, double-blind study to evaluate the safety, tolerability, PK, and PD of MEDI4166 administered as both single and multiple ascending doses to subjects with T2D.

Conditions
Type 2 Diabetes
Being tested
MEDI-4166, Placebo
Keywords
MEDI-4166, diabetes
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MEDI-4166Biological

    MEDI-4166 administered subcutaneously

  • PlaceboBiological

    Placebo administered subcutaneously

Study groups in NCT02524782
Study groupRoleWhat they receive
MEDI-4166ExperimentalMEDI-4166 administered subcutaneously
Receives: Biological: MEDI-4166
PlaceboPlacebo comparatorPlacebo administered subcutaneously
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

    Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)

    Measured: 43 days post dosing

  2. Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

    12 lead electrocardiogram including RR, PR, QRS, QT and QTc intervals

    Measured: 43 days post dosing

  3. Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

    Vital signs (systolic and diastolic blood pressure, pulse rate, temperature, and respiratory rate)

    Measured: 43 days post dosing

  4. Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

    Clinical laboratory assessments (serum chemistry, hematology, urinalysis)

    Measured: 43 days post dosing

  5. Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

    Physical examination

    Measured: 43 days post dosing

  6. Part B: Change in glucose AUC measured up to 240 minutes after mixed meal tolerance test (MMTT) from baseline to Day 36

    Part B: Change in glucose AUC measured up to 240 minutes after mixed meal tolerance test (MMTT) from baseline to Day 36

    Measured: 36 days post dosing

  7. Part B: Change in LDL-C from baseline to Day 36

    Part B: Change in LDL-C from baseline to Day 36

    Measured: 36 days post dosing

Secondary outcomes (16)

  1. Part A: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax)

    Part A: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax)

    Measured: 43 days post dosing

  2. Part A: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC)

    Part A: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC)

    Measured: 43 days post dosing

  3. Part A: Change from baseline in LDL-C

    Part A: Change from baseline in LDL-C

    Measured: 43 days post dosing

  4. Part A: Proportion of subjects with Anti-drug Antibodies (ADA) to MEDI4166

    Part A: Proportion of subjects with ADA to MEDI4166

    Measured: 43 days post dosing

  5. Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

    Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)

    Measured: 71 days post dosing

  6. Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

    12 lead electrocardiogram including RR, PR, QRS, QT and QTc intervals

    Measured: 71 days post dosing

  7. Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

    Vital signs (systolic and diastolic blood pressure, pulse rate, temperature, and respiratory rate)

    Measured: 71 days post dosing

  8. Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

    Clinical laboratory assessments (serum chemistry, hematology, urinalysis)

    Measured: 71 days post dosing

  9. Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

    Physical examination

    Measured: 71 days post dosing

  10. Part B: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax)

    Part B: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax)

    Measured: 71 days post dosing

  11. Part B: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC)

    Part B: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC)

    Measured: 71 days post dosing

  12. Part B: Change from baseline in fructosamine levels

    Part B: Change from baseline in fructosamine levels

    Measured: 36 days post dosing

  13. Part B: Proportion of subjects with ADA to MEDI4166

    Part B: Proportion of subjects with ADA to MEDI4166

    Measured: 71 days post dosing

  14. Part A: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax)

    Part A: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax)

    Measured: 43 days post dosing

  15. Part A: Change from baseline in glucose AUC up to 240 minutes

    Part A: Change from baseline in glucose AUC up to 240 minutes

    Measured: 43 days post dosing

  16. Part B: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax)

    Part B: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax)

    Measured: 71 days post dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2015 (estimated)
  2. Study start7 Oct 2015
  3. Primary completion14 Apr 2017
  4. Study completion14 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02524782
Sponsor's protocol ID
D6240C00001
Status last verified
Mar 2018
First submitted
13 Aug 2015
Last updated
13 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Jain M, Carlson G, Cook W, Morrow L, Petrone M, White NE, Wang T, Naylor J, Ambery P, Lee C, Hirshberg B. Randomised, phase 1, dose-finding study of MEDI4166, a PCSK9 antibody and GLP-1 analogue fusion molecule, in overweight or obese patients with type 2 diabetes mellitus. Diabetologia. 2019 Mar;62(3):373-386. doi: 10.1007/s00125-018-4789-6. Epub 2018 Dec 28.

    PubMed 30593607

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MEDI-4166 in people with Type 2 Diabetes, run by MedImmune LLC at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166 (time frame: 43 days post dosing). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02524782, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.

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Clinical Trial NCT02524782 | AzTrials