LivingGLP1
Study S003298

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DD01 in Overweight/Obese Subjects With T2DM and NAFLD

ClinicalTrials.gov record

Registration

Registration
NCT04812262
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE1
Masking
QUADRUPLE
Status
COMPLETED
Enrollment
255
Start
2021-02-24
Primary completion
2022-12-20
Lead sponsor
Neuraly, Inc.
Conditions
Overweight and Obesity; Type2 Diabetes; NAFLD
Interventions
DRUG:DD01; DRUG:Placebo
Results posted
FALSE
Individual participant data sharing
NO

Registered primary outcomes

  • Number of participants with treatment-related adverse events and serious adverse events [Part A - 43 days]
  • Number of participants with treatment-related adverse events and serious adverse events (TEAEs) [Part B - 57 days]
  • Number of participants with clinically significant abnormalities in clinical laboratory values [Part A - 43 days]
  • Number of participants with clinically significant abnormalities in clinical laboratory values [Part B - 57 days]
  • Number of participants with clinically significant abnormalities in physical examinations [Part A - 43 days]
  • Number of participants with clinically significant abnormalities in physical examinations [Part B - 57 days]
  • Number of participants with clinically significant abnormalities in vital signs [Part A - 43 days]
  • Number of participants with clinically significant abnormalities in vital signs [Part B - 57 days]
  • Blood Pressure assessed by 24-hour ambulatory blood pressure monitoring (ABPM) [Part A - 43 days]
  • Blood Pressure assessed by 24-hour ambulatory blood pressure monitoring (ABPM) [Part B - 57 days]
  • Heart Rate assessed by 24-hour ambulatory electrocardiography monitoring reader) [Part A - 43 days]
  • Heart Rate assessed by 24-hour ambulatory electrocardiography monitoring reader) [Part B - 57 days]
  • Number of participants with clinically significant abnormalities in 12-lead ECGs [Part A - 43 days]
  • Number of participants with clinically significant abnormalities in 12-lead ECGs [Part B - 57 days]

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