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Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist

Cotadutide for Liver Disease

Phase 1
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of first dose to the final follow-up visit (day 29)
Awards & highlights

Study Summary

This trial will study the effects of a new drug, cotadutide, in patients with different levels of liver function. The goal is to see if the drug is safe and effective in these patients.

Eligible Conditions
  • Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of first dose to the final follow-up visit (day 29)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of first dose to the final follow-up visit (day 29) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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)
+4 more
Secondary outcome measures
Incidence of ADAs (anti-drug antibodies)
Number of participants with Adverse Events (AEs)

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4Experimental Treatment1 Intervention
Participants in each cohort will receive Dose A cotadutide subcutaneously.
Group II: Cohort 3Experimental Treatment1 Intervention
Participants in each cohort will receive Dose A cotadutide subcutaneously.
Group III: Cohort 2Experimental Treatment1 Intervention
Participants in each cohort will receive Dose A cotadutide subcutaneously.
Group IV: Cohort 1Experimental Treatment1 Intervention
Participants in each cohort will receive Dose A cotadutide subcutaneously.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cotadutide
2020
Completed Phase 1
~20

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,274 Previous Clinical Trials
288,613,397 Total Patients Enrolled
ParexelIndustry Sponsor
304 Previous Clinical Trials
101,128 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies remaining in this research endeavor?

"Concurrently, the trial is actively recruiting participants - first posted on September 6th 2022 and recently updated November 24th 2022."

Answered by AI

In which demographic is enrollment in this trial being sought?

"This clinical trial is searching for 32 people aged between 18 and 85 that are suffering from hepatic impairment. In order to be eligible, applicants must meet these criteria."

Answered by AI

What is the current sample size for this research project?

"Affirmative, the details on clinicaltrials.gov demonstrate that this medical trial is currently signing up participants. The initial posting was September 6th 2022 and it has since been modified November 24th of the same year. 32 patients must be admitted from 3 sites for the research to proceed as planned."

Answered by AI

What detrimental effects could Cotadutide have on individuals?

"Due to the limited evidence of safety and efficacy, our team at Power assigned Cotadutide a score of 1 on its scale from 1 to 3."

Answered by AI

Does this clinical trial consider participants of eligible age?

"This research project has an age bracket requirement, with 18 being the minimum cut-off and 85 as the upper limit."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pharmacokinetics of Cotadutide in Participants With Hepatic Impairment
2022. "Pharmacokinetics of Cotadutide in Participants With Hepatic Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05517226.
~9 spots leftby May 2025
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