Safety and Pharmacokinetics Study of MBX 2109 in Adult Subjects With Normal and Impaired Renal Function

NCT06496217 | Completed Phase 1 FDA Drug

• 1 other identifier: MBX-2H1003
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

Brief Summary

Evaluate the Safety and Pharmacokinetics of MBX 2109 in Adult Subjects with Normal and Impaired Renal Function

Conditions

Renal Impairment

Outcome Measures

Primary Outcomes (7)

• 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

  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

  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

  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

  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

  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

  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

  Baseline through Day 36

Study Arms (1)

Single 900 µg dose of MBX 2109

EXPERIMENTAL

A single, 900 µg dose of MBX 2109 will be administered subcutaneously in the abdomen

Drug: MBX 2109

Interventions

MBX 2109 DRUG

Group 1: Subjects with mild renal impairment (eGFR ≥ 60 and \< 90 mL/min)

Single 900 µg dose of MBX 2109

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.
• Any skin condition and/or tattoo that may interfere with the injection site evaluation.

Sponsors & Collaborators

• MBX Biosciences: lead

Study Sites (3)

MBX Biosciences Investigational Site

Miami, Florida, 33136, United States

Location

MBX Bioscience Investigational Site

Tampa, Florida, 33603, United States

Location

MBX Biosciences Investigational Site

Minneapolis, Minnesota, 55101, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: July 11, 2024
• Study Start: June 13, 2024
• Primary Completion: September 4, 2025
• Study Completion: September 4, 2025
• Last Updated: October 28, 2025

Record last verified: 2025-10

Locations

US (3)