A Study of Cotadutide in Participants Who Have Chronic Kidney Disease With Type 2 Diabetes Mellitus

Sponsor
AstraZeneca
Study ID
NCT04515849
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Cotadutide 100 micrograms — DRUG
    Cotadutide 100 micrograms administered subcutaneously
  • Cotadutide 300 micrograms — DRUG
    Cotadutide 300 micrograms administered subcutaneously
  • Cotadutide 600 micrograms — DRUG
    Cotadutide 600 micrograms administered subcutaneously
  • Semaglutide — DRUG
    Semaglutide 1.0 miligrams administered subcutaneously
  • Placebo — DRUG
    Placebo administered subcutaneously

Study Details

A Phase 2b, study to measure the effect of Cotadutide at different doses versus placebo or comparator (semaglutide) in participants who have Chronic Kidney Disease with Type 2 Diabetes Mellitus.

Key Dates

Start date
Aug 31, 2020
Status verified
Dec 2024
Primary completion
Mar 8, 2022
Completion
Mar 8, 2022

Study Design

Enrollment
248 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cotadutide 100 micrograms
    Cotadutide 100 micrograms administered subcutaneously
  • Experimental: Cotadutide 300 micrograms
    Cotadutide 300 micrograms administered subcutaneously
  • Experimental: Cotadutide 600 micrograms
    Cotadutide 600 micrograms administered subcutaneously
  • Placebo Comparator: Placebo
    Placebo administered subcutaneously
  • Active Comparator: Semaglutide
    Semaglutide 1.0 miligrams administered subcutaneously

Primary Outcome Measure

The Primary Endpoint Was Percentage Change in UACR of Cotadutide at Different Dose Levels Compared to Placebo After 14 Weeks [ Time Frame: Baseline to the end of 14 weeks of dosing ]

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