LivingGLP1
Study S001644

A Randomized, Blinded, Placebo-controlled Study to Assess Pharmacokinetics, Safety, and Tolerability of Ascending Doses of MEDI0382 in Non-diabetic Obese Subjects

ClinicalTrials.gov record

Registration

Registration
NCT03625778
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE1
Masking
TRIPLE
Status
COMPLETED
Enrollment
51
Start
2018-08-14
Primary completion
2019-08-25
Lead sponsor
MedImmune LLC
Conditions
Obesity
Interventions
DRUG:MEDI0382; DRUG:Placebo
Results posted
FALSE
Individual participant data sharing
YES

Registered primary outcomes

  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) for Cohorts 1, 2, and 3 [From Day 1 through 28 days after the last dose of study drug (approximately 13, 18, and 22 weeks for Cohorts 1, 2, and 3, respectively)]
  • Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs for Cohorts 1, 2, and 3 [From Day 1 through 28 days after the last dose of study drug (approximately 13, 18, and 22 weeks for Cohorts 1, 2, and 3, respectively)]
  • Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs for Cohorts 1, 2, and 3 [From Day 1 through 28 days after the last dose of study drug (approximately 13, 18, and 22 weeks for Cohorts 1, 2, and 3, respectively)]
  • Number of Participants With Abnormal Electrocardiogram (ECG) Parameters Reported as TEAEs for Cohorts 1, 2, and 3 [From Day 1 through 28 days after the last dose of study drug (approximately 13, 18, and 22 weeks for Cohorts 1, 2, and 3, respectively)]
  • Change in Blood Pressure from Baseline to End of Dosing as Measured by Telemetry for Cohort 1 [From Baseline (Day -1) through end of dosing (Day 63)]
  • Change in Respiratory Rate from Baseline to End of Dosing as Measured by Telemetry for Cohort 1 [From Baseline (Day -1) through end of dosing (Day 63)]
  • Change in Pulse Rate from Baseline to End of Dosing as Measured by Telemetry for Cohort 1 [From Baseline (Day -1) through end of dosing (Day 63)]
  • Change in Temperature from Baseline to End of Dosing as Measured by Telemetry for Cohort 1 [From Baseline (Day -1) through end of dosing ( Day 63)]

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