Renal ImpairmentPhase 1NCT06496217
Safety and Pharmacokinetics Study of MBX 2109 in Adult Subjects With Normal and Impaired Renal Function
A Phase 1 study testing MBX 2109 in people with Renal Impairment, run by MBX Biosciences at 3 sites in United States.
Trial summary
Evaluate the Safety and Pharmacokinetics of MBX 2109 in Adult Subjects with Normal and Impaired Renal Function Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- MBX 2109
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Jun 2024to 4 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willingness to adhere to the Protocol requirements as evidenced by a signed and dated informed consent form (ICF)
- Subject is, as stated and in the opinion of the Investigator, willing and able to comply with the study drug regimen and all other study procedures and requirements, and is available for the duration of the study
- Adult male or female, of at least 18 years of age, but not older than 80 years
- Subject is willing to comply with the contraceptive requirements.
- BMI ≥ 18.5 kg/m2 and < 40.0 kg/m2 at the time of Screening.
- Light-, non- or ex-smoker
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- Has suitable venous access for blood sampling
- Subjects with Normal Renal Function (Group 4):
- Medically healthy, in the opinion of an Investigator, with clinically insignificant Screening results (eg, laboratory profiles, medical history, vital signs, ECG, physical examination)
- Normal renal function with eGFR ≥ 90 mL/min at Screening
- Must match to the pooled mean age (± 10 years), BMI (within 20%) and gender (ratio should be similar) of mild, moderate, and severe (if applicable) renal impaired subjects at Screening.
- Subjects with Mild, Moderate, and Severe Renal Impaired Function (Groups 1, 2, and 3):
- Considered clinically stable in the opinion of an Investigator
- Presence of mild renal impairment (eGFR ≥ 60 and <90 mL/min), moderate renal impairment (eGFR ≥ 30 and <60 mL/min), or severe renal impairment (eGFR <30 mL/min) or kidney failure not receiving dialysis, at Screening: renal impairment should have been stable for at least 1 month prior to Screening.
Who cannot join
- Female who is lactating or breastfeeding
- Female who is pregnant according to the pregnancy test at Screening or prior to study drug administration or planning to become pregnant before 90 days after the last study drug administration.
- History of significant hypersensitivity to MBX 2109 or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs.
- History of, or positive test for hepatitis B surface antigen (HbsAg), hepatitis C antibody (HCV Ab), or HIV antibody, at Screening.
- Presence or history of any disorder that could interfere with completion of the study based on the opinion of an Investigator.
- Intake of MBX 2109, or any investigational product (IP) in the 28 days prior to study drug administration.
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- Have urinary incontinence without catheterization
- Receipt of blood products within 3 months prior to study drug administration.
- Donation of 50 mL or more of blood in the 28 days prior to study drug administration
- Donated 500 mL or more of blood within 56 days prior to study drug administration
- Donated plasma within 2 weeks prior to Screening or donated platelets within 6 weeks prior to Screening.
- Immunization with a Coronavirus Disease 2019 (COVID-19) vaccine in the 14 days prior to the first study drug administration.
- Scheduled immunization with a COVID-19 vaccine during the study that, in the opinion of an Investigator, could potentially interfere with subject participation, subject safety, study results, or any other reason.
- Use of St. John's wort in the 28 days prior to the first study drug administration.
- Inclusion in a previous group for this clinical study
- Any skin condition and/or tattoo that may interfere with the injection site evaluation.
- Subjects with Normal Renal Function (Group 4):
- Presence of significant gastrointestinal, liver, or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs or known to potentiate or predispose to undesired effects.
- History of significant gastrointestinal, liver, or kidney disease that may affect drug bioavailability.
- Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease.
- Presence of clinically significant ECG abnormalities at the Screening visit, as defined by medical judgment.
- Positive test result for alcohol and/or drugs of abuse at Screening or prior to the first study drug administration.
- Supine or semi-supine blood pressure below 90/50 mmHg at the Screening visit
- Supine or semi-supine blood pressure higher than 140/90 mmHg at the Screening visit (blood pressure readings greater than 140/90 mmHg may be retested if completed thought to be influenced by stress, at the discretion of the Investigator).
- Supine or semi-supine pulse rate less than 40 beats per minute (bpm) or more than 100 bpm at Screening.
- Any clinically significant illness in the 28 days before Day 1 of the study
- Use of any prescription drugs (with the exception of hormonal contraceptives or hormone replacement therapy) in the 28 days before Day 1 of the study.
- Use of over-the-counter (OTC) drugs and natural health products (eg, herbal remedies) at least 7 days (or 5-times the half-life of the drug, if longer) prior to study drug administration.
- Use of any enzyme-modifying drugs, or drugs with effects on membrane transporters, including any strong cytochrome P450 3A4 and P-glycoprotein inducers and inhibitors in the previous 28 days before Day 1 of the study.
- Subjects with Mild, Moderate, and Severe Renal Impaired Function (Groups 1, 2, and 3):
- History of renal transplant
- Supine or semi-supine blood pressure below 90/50 mmHg at the Screening visit.
- Supine or semi-supine blood pressure higher than 180/110 mmHg at the Screening visit.
- Supine or semi-supine pulse rate less than 45 bpm or more than 110 bpm at Screening.
- History or presence, in the opinion of an Investigator, of significant clinically unstable respiratory, cardiovascular, pulmonary, hepatic, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
- Presence of poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c > 10%.
- Presence of clinically significant physical examination, laboratory test, or ECG finding that, in the opinion of an Investigator and/or Sponsor, may interfere with any aspect of study conduct or interpretation of results.
- Subjects requiring treatment for renal impairment or other chronic disease (eg, well controlled diabetes, hypertension) must be on a stable treatment plan (medicines, doses, and regimens) for at least 14 days (except insulin) prior to study drug administration and during the entire study.
- Positive Screening of alcohol and/or drugs of abuse at Screening or prior to study drug administration unless results can be explained by a prescription medication.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
MBX Biosciences Investigational Site
Miami, Florida, 33136
MBX Biosciences Investigational Site
Minneapolis, Minnesota, 55101
MBX Bioscience Investigational Site
Tampa, Florida, 33603
About this study
Official title: A Phase 1, Open-Label, Parallel-Group, Single Dose Adaptive Study to Evaluate the Safety and Pharmacokinetics of MBX 2109 in Adult Subjects With Normal and Impaired Renal Function
Evaluate the Safety and Pharmacokinetics of MBX 2109 in Adult Subjects with Normal and Impaired Renal Function
Read the detailed description
A Phase 1, Open-Label, Parallel-Group, Single-Dose Adaptive Study to Evaluate the Safety and Pharmacokinetics of MBX 2109 in Adult Subjects with Normal and Impaired Renal Function
- Conditions
- Renal Impairment
- Being tested
- MBX 2109
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBX 2109Drug
Group 1: Subjects with mild renal impairment (eGFR ≥ 60 and < 90 mL/min)
MBX 2109Drug
Group 2: Subjects with moderate renal impairment (eGFR ≥ 30 and < 60 mL/min)
MBX 2109Drug
Group 3: Subjects with severe renal impairment (eGFR < 30 mL/min), or kidney failure and not receiving dialysis
MBX 2109Drug
Group 4: Matched healthy subjects with normal renal function (eGFR ≥ 90 mL/min)
| Study group | Role | What they receive |
|---|---|---|
| Single 900 µg dose of MBX 2109 | Experimental | A single, 900 µg dose of MBX 2109 will be administered subcutaneously in the abdomen Receives: Drug: MBX 2109 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-∞)
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Measured: Baseline through Day 36
Maximum observed concentration (Cmax)
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Measured: Baseline through Day 36
Area under the plasma concentration-time curve from time 0 to time of last quantifiable sample (AUC0-T)
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Measured: Baseline through Day 36
Apparent clearance (CL/F) (MBX 2109 only)
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Measured: Baseline through Day 36
Time to maximum concentration (Tmax)
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Measured: Baseline through Day 36
Terminal elimination half-life (t1/2)
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Measured: Baseline through Day 36
Apparent volume of distribution (Vz/F) (MBX 2109 only)
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Measured: Baseline through Day 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start13 Jun 2024
- Primary completion4 Sep 2025
- Study completion4 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- MBX Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496217
- Sponsor's protocol ID
- MBX-2H1003
- Status last verified
- Oct 2025
- First submitted
- 12 Jun 2024
- Last updated
- 28 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Parallel-Group, Single Dose Adaptive Study to Evaluate the Safety and Pharmacokinetics of MBX 2109 in Adult Subjects With Normal and Impaired Renal Function
- ClinicalTrials.gov ID
- NCT06496217
- Acronym / sponsor ID
- MBX-2H1003
- Conditions
- Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- MBX BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 4 Sep 2025 (actual)
- Study completion
- 4 Sep 2025 (actual)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the Safety and Pharmacokinetics of MBX 2109 in Adult Subjects with Normal and Impaired Renal Function
Detailed description
A Phase 1, Open-Label, Parallel-Group, Single-Dose Adaptive Study to Evaluate the Safety and Pharmacokinetics of MBX 2109 in Adult Subjects with Normal and Impaired Renal Function
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single 900 µg dose of MBX 2109 | Experimental | Drug: MBX 2109A single, 900 µg dose of MBX 2109 will be administered subcutaneously in the abdomen |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Willingness to adhere to the Protocol requirements as evidenced by a signed and dated informed consent form (ICF)
- Subject is, as stated and in the opinion of the Investigator, willing and able to comply with the study drug regimen and all other study procedures and requirements, and is available for the duration of the study
- Adult male or female, of at least 18 years of age, but not older than 80 years
- Subject is willing to comply with the contraceptive requirements.
- BMI ≥ 18.5 kg/m2 and < 40.0 kg/m2 at the time of Screening.
Key exclusion criteria (39 listed)
- Female who is lactating or breastfeeding
- Female who is pregnant according to the pregnancy test at Screening or prior to study drug administration or planning to become pregnant before 90 days after the last study drug administration.
- History of significant hypersensitivity to MBX 2109 or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs.
- History of, or positive test for hepatitis B surface antigen (HbsAg), hepatitis C antibody (HCV Ab), or HIV antibody, at Screening.
- Presence or history of any disorder that could interfere with completion of the study based on the opinion of an Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBX 2109Group 1: Subjects with mild renal impairment (eGFR ≥ 60 and < 90 mL/min) | Drug | Single 900 µg dose of MBX 2109 |
| MBX 2109Group 2: Subjects with moderate renal impairment (eGFR ≥ 30 and < 60 mL/min) | Drug | Single 900 µg dose of MBX 2109 |
| MBX 2109Group 3: Subjects with severe renal impairment (eGFR < 30 mL/min), or kidney failure and not receiving dialysis | Drug | Single 900 µg dose of MBX 2109 |
| MBX 2109Group 4: Matched healthy subjects with normal renal function (eGFR ≥ 90 mL/min) | Drug | Single 900 µg dose of MBX 2109 |
Primary outcome
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-∞)
Time frame: Baseline through Day 36
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Maximum observed concentration (Cmax)
Time frame: Baseline through Day 36
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Area under the plasma concentration-time curve from time 0 to time of last quantifiable sample (AUC0-T)
Time frame: Baseline through Day 36
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Apparent clearance (CL/F) (MBX 2109 only)
Time frame: Baseline through Day 36
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Time to maximum concentration (Tmax)
Time frame: Baseline through Day 36
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Terminal elimination half-life (t1/2)
Time frame: Baseline through Day 36
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Apparent volume of distribution (Vz/F) (MBX 2109 only)
Time frame: Baseline through Day 36
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MBX 2109 in people with Renal Impairment, run by MBX Biosciences at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-∞) (time frame: Baseline through Day 36). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2025.