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AZD4076

Phase 1

T2DM With NAFLD | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Apr 1, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02826525AZD4076 in Type 2 Diabetic Subjects With Non-Alcoholic Fatty Liver Disease.PHASE1 COMPLETED 14 — — Jul 18, 2016Oct 11, 2019Apr 1, 2021 - —
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Study Endpoints
Primary Endpoints
The safety and tolerability of AZD4076 by assessing the number of participants with adverse events
From screening until 26 weeks post first dose

To assess the safety and tolerability of multiple ascending doses of AZD4076

The safety and tolerability of AZD4076 by assessment of blood pressure
From screening until 26 weeks post first dose

To assess the safety and tolerability of multiple ascending doses of AZD4076

The safety and tolerability of AZD4076 by assessment of pulse
From screening until 26 weeks post first dose

To assess the safety and tolerability of multiple ascending doses of AZD4076

The safety and tolerability of AZD4076 by assessment of oral temperature
From day -2 until day 42

To assess the safety and tolerability of multiple ascending doses of AZD4076

The safety and tolerability of AZD4076 by assessment of electrocardiogram readings
From screening until 26 weeks post first dose

To assess the safety and tolerability of multiple ascending doses of AZD4076

The safety and tolerability of AZD4076 by assessment of digital electrocardiogram readings
From predose until 24 hours post-dose on days 1 and 42

To assess the safety and tolerability of multiple ascending doses of AZD4076

The safety and tolerability AZD4076 by assessment of physical examination
From screening until 26 weeks post first dose

Percentage of patients with abnormal physical examination

The safety and tolerability of AZD4076 by assessing the injection site
From day 1 until day 42

Percentage of patients with dermatological adverse events

The safety and tolerability of AZD4076 by assessing the number of adverse events
From screening until 26 weeks post first dose

To assess the safety and tolerability of multiple ascending doses of AZD4076

The safety and tolerability of AZD4076 by assessing hematology
From screening until 26 weeks post first dose

To assess the safety and tolerability of multiple ascending doses of AZD4076

The safety and tolerability of AZD4076 by assessing clinical chemistry
From screening until 26 weeks post first dose

Percentage of patients with clinically significant changes in laboratory tests.

The safety and tolerability of AZD4076 by assessing urinalysis
From screening until 26 weeks post-first dose

To assess the safety and tolerability of multiple ascending doses of AZD4076

Glucose infusion rate at hyperinsulinemic clamp
Day -1 and 56 days post first dose

To assess the effect of AZD4076 on whole body insulin sensitivity using hyperinsulinemic euglycemic clamp with tracer technique

Reduction in liver fat content (%) per MRI
Screening and 54 days post first dose

To assess the effect of AZD4076 on liver fat content using magnetic resonance imaging

Secondary Endpoints
24 hour glucose area under the curve
Day -2 and day 55
HOMA-IR
Day -2 and day 55
Fasting Endogenous Glucose Production
Day -1 and day 56
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TreatmentEXPERIMENTALSubjects in this arm will receive AZD4076
ControlPLACEBO_COMPARATORSubjects in this arm will receive placebo
Interventions
NameTypeDescription
AZD4076DRUGInvestigational product
PlaceboDRUGControl
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo

Inclusion criteria 1. Provision of signed and dated, written informed consent prior to any study specific procedures. 2. Males or females of non-child bearing potential. 3. Age 18-70 years with suitable veins for cannulation or repeated venipuncture. 4. BMI 23-40 kg/m2 inclusive. 5. Diagnosed T2D (...

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