A Multiple-ascending-dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of MEDI0382 in Overweight and Obese Participants With Type 2 Diabetes Mellitus
NCT ID: NCT02548585
Last Updated: 2019-04-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
113 participants
INTERVENTIONAL
2015-12-09
2017-02-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants will receive placebo (matched to either 100 micrograms \[mcg\], or 150 mcg or 200 mcg or 300 mcg of MEDI0382) subcutaneously (SC) once daily from Day 1 to Day 7 (Cohort 1); or Day 1 to Day 11 (Cohort 2); or Day 1 to Day 15 (Cohort 3); or Day 1 to Day 41 (Cohort 4); or Day 1 to Day 22 (Cohort 5); or Day 1 to Day 17 (Cohort 6).
Placebo
Placebo administered subcutaneously.
Cohort 1: MEDI0382 100 mcg
Participants will receive MEDI0382 100 mcg SC once daily from Day 1 to Day 7.
MEDI0382
MEDI0382 administered subcutaneously.
Cohort 2: MEDI0382 150 mcg
Participants will receive MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).
MEDI0382
MEDI0382 administered subcutaneously.
Cohort 3: MEDI0382 200 mcg
Participants will receive MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15).
MEDI0382
MEDI0382 administered subcutaneously.
Cohort 4: MEDI0382 200 mcg
Participants will receive MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).
MEDI0382
MEDI0382 administered subcutaneously.
Cohort 5: MEDI0382 300 mcg
Participants will receive MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).
MEDI0382
MEDI0382 administered subcutaneously.
Cohort 6: MEDI0382 300 mcg
Participants will receive MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).
MEDI0382
MEDI0382 administered subcutaneously.
Interventions
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MEDI0382
MEDI0382 administered subcutaneously.
Placebo
Placebo administered subcutaneously.
Eligibility Criteria
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Inclusion Criteria
* Must provide written informed consent
* Body mass index greater than (\>) 27 and less than (\<) 40 kg/m\^2, inclusive
* 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
Exclusion Criteria
* 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 within the last 10 years, with the exception of non-melanoma skin cancer
* Any clinically important illness (except for T2DM), medical/surgical procedure, or trauma within 4 weeks prior to dosing
* Fasting glucose greater than or equal to (\>=) 200 mg/dL
* Positive Hepatitis B, Hepatitis C or human immunodeficiency virus test or use of antiretroviral medications at screening.
* Concurrent or previous use of a glucagon-like peptide 1 receptor agonist
* 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 control of body weight or appetite is prohibited.
* Known or suspected history of alcohol or drug abuse within the past 3 years.
* Positive drug screen
18 Years
65 Years
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Stumvoll
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Leipzig
Locations
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Research Site
Berlin, , Germany
Research Site
Erfurt, , Germany
Research Site
Kiel, , Germany
Research Site
Leipzig, , Germany
Research Site
Lübeck, , Germany
Research Site
Magdeburg, , Germany
Research Site
Mainz, , Germany
Research Site
Mannheim, , Germany
Research Site
München, , Germany
Research Site
Neu-Ulm, , Germany
Research Site
Neuss, , Germany
Countries
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References
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Bosch R, Petrone M, Arends R, Vicini P, Sijbrands EJG, Hoefman S, Snelder N. Characterisation of cotadutide's dual GLP-1/glucagon receptor agonistic effects on glycaemic control using an in vivo human glucose regulation quantitative systems pharmacology model. Br J Pharmacol. 2024 Jun;181(12):1874-1885. doi: 10.1111/bph.16336. Epub 2024 Feb 25.
Ambery P, Parker VE, Stumvoll M, Posch MG, Heise T, Plum-Moerschel L, Tsai LF, Robertson D, Jain M, Petrone M, Rondinone C, Hirshberg B, Jermutus L. MEDI0382, a GLP-1 and glucagon receptor dual agonist, in obese or overweight patients with type 2 diabetes: a randomised, controlled, double-blind, ascending dose and phase 2a study. Lancet. 2018 Jun 30;391(10140):2607-2618. doi: 10.1016/S0140-6736(18)30726-8. Epub 2018 Jun 23.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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D5670C00002 Protocol\_Amendment\_8-redacted\_correct\_PDF-A
Statistical\_Analysis\_Plan\_MEDI0382\_D5670C00002\_Redacted\_PDF-A
Other Identifiers
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D5670C00002
Identifier Type: -
Identifier Source: org_study_id
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