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MBX 2109 for Kidney Failure

Phase 1
Recruiting
Research Sponsored by MBX Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult male or female, of at least 18 years of age, but not older than 80 years
Normal renal function with eGFR ≥ 90 mL/min at Screening
Must not have
Presence of significant gastrointestinal, liver, or kidney disease, or any other conditions known to interfere with drug effects
Intake of MBX 2109, or any investigational product (IP) in the 28 days prior to study drug administration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through day 36
Awards & highlights

Summary

This trial will test the safety and how the body processes a drug called MBX 2109 in adults with both normal and impaired kidney function.

Who is the study for?
Adults aged 18-80 with either normal kidney function or varying degrees of impaired renal function, who are non-smokers or light smokers, and have a BMI between 18.5 and 40 kg/m2. Participants must be willing to follow the study's procedures and contraceptive requirements. Those with significant health issues, recent drug use, or unstable chronic diseases cannot join.
What is being tested?
The trial is testing MBX 2109 to see how safe it is and how it moves through the bodies of adults with different levels of kidney health. It will compare those with normal kidney function to those with mild, moderate, or severe impairment.
What are the potential side effects?
While specific side effects for MBX 2109 aren't listed here, common side effects in trials like this may include reactions at the injection site, nausea, headaches, fatigue or allergic responses among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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My kidney function is normal, with an eGFR of 90 mL/min or higher.
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My kidneys are not working well but I am not on dialysis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe GI, liver, or kidney disease that could affect drug absorption.
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I haven't taken MBX 2109 or any experimental drugs in the last 28 days.
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I have had a kidney transplant.
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My diabetes is not well-managed.
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I am currently breastfeeding.
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I am pregnant or planning to become pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through day 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through day 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Apparent clearance (CL/F) (MBX 2109 only)
Apparent volume of distribution (Vz/F) (MBX 2109 only)
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-∞)
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single 900 µg dose of MBX 2109Experimental Treatment1 Intervention
A single, 900 µg dose of MBX 2109 will be administered subcutaneously in the abdomen

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

MBX BiosciencesLead Sponsor
4 Previous Clinical Trials
256 Total Patients Enrolled
~0 spots leftby Oct 2024
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