Cotadutide for Hepatic Impairment

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Research Site, Rialto, CA
Hepatic Impairment+1 More
Cotadutide - CombinationProduct
Eligibility
18+
All Sexes
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Study Summary

This study will assess the pharmacokinetics (PK), safety, and tolerability of a single subcutaneous injection of cotadutide in participants with mild, moderate or severe hepatic impairment compared to participants with normal hepatic function.

Eligible Conditions

  • Hepatic Impairment

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Hepatic Impairment

Study Objectives

7 Primary · 2 Secondary · Reporting Duration: From time of first dose to the final follow-up visit (Day 29)

Day 3
Apparent total body clearance (CL/F)
Apparent volume of distribution based on the terminal phase (Vz/F)
Area under plasma concentration time curve from zero to infinity (AUCinf)
Area under the plasma concentration-curve from time zero to last quantifiable concentration (AUClast)
Maximum observed plasma (peak) drug concentration [Cmax]
Terminal half-life (t½λz)
Time to reach peak or maximum observed concentration or response following drug administration (tmax)
Day 29
Incidence of ADAs (anti-drug antibodies)
Number of participants with Adverse Events (AEs)

Trial Safety

Safety Progress

1 of 3

Other trials for Hepatic Impairment

Trial Design

4 Treatment Groups

Cohort 4
1 of 4
Cohort 3
1 of 4
Cohort 1
1 of 4
Cohort 2
1 of 4
Experimental Treatment

32 Total Participants · 4 Treatment Groups

Primary Treatment: Cotadutide · No Placebo Group · Phase 1

Cohort 4
CombinationProduct
Experimental Group · 1 Intervention: Cotadutide · Intervention Types: CombinationProduct
Cohort 3
CombinationProduct
Experimental Group · 1 Intervention: Cotadutide · Intervention Types: CombinationProduct
Cohort 1
CombinationProduct
Experimental Group · 1 Intervention: Cotadutide · Intervention Types: CombinationProduct
Cohort 2
CombinationProduct
Experimental Group · 1 Intervention: Cotadutide · Intervention Types: CombinationProduct
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cotadutide
2020
Completed Phase 1
~20

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from time of first dose to the final follow-up visit (day 29)
Closest Location: Research Site · Rialto, CA
1900First Recorded Clinical Trial
6 TrialsResearching Hepatic Impairment
2948 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Female participants of childbearing potential must use at least one highly effective form of birth control.
You are of a gender matched to your matched participant enrolled in the study.
You are within ±10 years of your matched participant.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.