NCT02524782

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P75+ for phase_1 type-2-diabetes

Timeline
Completed

Started Oct 2015

Longer than P75 for phase_1 type-2-diabetes

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 17, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

October 7, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2017

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2018

Enrollment Period

1.5 years

First QC Date

August 13, 2015

Last Update Submit

March 12, 2019

Conditions

Type 2 Diabetes

Keywords

MEDI-4166, diabetes

Outcome Measures

Primary Outcomes (7)

  • 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)

    43 days post dosing

  • 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

    43 days post dosing

  • 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)

    43 days post dosing

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

    Clinical laboratory assessments (serum chemistry, hematology, urinalysis)

    43 days post dosing

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

    Physical examination

    43 days post dosing

  • 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

    36 days post dosing

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

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

    36 days post dosing

Secondary Outcomes (16)

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

    43 days post dosing

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

    43 days post dosing

  • Part A: Change from baseline in LDL-C

    43 days post dosing

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

    43 days post dosing

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

    71 days post dosing

  • +11 more secondary outcomes

Study Arms (2)

MEDI-4166

EXPERIMENTAL

MEDI-4166 administered subcutaneously

Biological: MEDI-4166

Placebo

PLACEBO COMPARATOR

Placebo administered subcutaneously

Biological: Placebo

Interventions

MEDI-4166BIOLOGICAL

MEDI-4166 administered subcutaneously

MEDI-4166
PlaceboBIOLOGICAL

Placebo administered subcutaneously

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Use of any medicinal products or herbal preparations licensed for weight loss is prohibited.
  • Positive drug screen
  • Type 1 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Research Site

Anniston, Alabama, 36207, United States

Location

Research Site

Chula Vista, California, 91911, United States

Location

Research Site

Jacksonville, Florida, 32216, United States

Location

Research Site

Miami, Florida, 33014, United States

Location

Research Site

South Miami, Florida, 33143, United States

Location

Research Site

Durham, North Carolina, 27710, United States

Location

Research Site

Raleigh, North Carolina, 27612, United States

Location

Research Site

Cincinnati, Ohio, 45227, United States

Location

Research Site

Knoxville, Tennessee, 37920, United States

Location

Research Site

San Antonio, Texas, 78209, United States

Location

Research Site

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

  • 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.

    PMID: 30593607DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2015

First Posted

August 17, 2015

Study Start

October 7, 2015

Primary Completion

April 14, 2017

Study Completion

April 14, 2017

Last Updated

March 13, 2019

Record last verified: 2018-03

Locations

US(11)