imapextide (MBX 1416) / MBX Biosci - LARVOL DELTA

Study to Evaluate Efficacy and Dose Response of Imapextide (STEADI) (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: MBX Biosciences | Not yet recruiting ➔ Recruiting

Enrollment open • Hypoglycemia

Safety and Pharmacokinetics of MBX 1416, a Glucagon-Like Peptide 1 Receptor Antagonist, in Healthy Volunteers—A Phase 1 Randomized Trial (ADA 2025) - P1 | "In HVs, MBX 1416 was generally well tolerated, with PK supporting weekly dosing, PD showing an apparent effect on GLP-1, and minimal DDI with rosuvastatin PK."

Clinical • P1 data • PK/PD data • Hypoglycemia • Metabolic Disorders

MBX 1416, a Selective GLP-1 Antagonist, Elevates and Sustains Blood Glucose in Rats without Change in Body Weight (ADA 2025) - "Differential effects of MBX 1416 on glucose elevation following glucose challenge in DIO mice vs an unmodified GLP-1 antagonist exendin 9-39 (Ex9) were assessed with an intraperitoneal glucose tolerance test (IPGTT) 24 h post dosing to highlight MBX 1416's lengthy time action. Dose-proportional plasma MBX 1416 exposures were seen with a single dose (Cmax and AUCinf, ≤2-fold across doses). MBX 1416 demonstrated expected PK/PD effects in rats, increasing blood glucose excursions in DIO mice with no change in food intake or body weight vs vehicle in healthy rats."

Preclinical • Hypoglycemia • Metabolic Disorders

A Study to Investigate Preliminary Efficacy of Subcutaneous MBX 1416 in Participants With Documented Postbariatric Hypoglycemia (clinicaltrials.gov) - P2 | N=10 | Not yet recruiting | Sponsor: MBX Biosciences

New P2 trial • Hypoglycemia

Post-bariatric Hypoglycemia (PBH): MBX 1416 (GlobeNewswire) - "MBX anticipates initiating a Phase 2 study of MBX 1416 in patients with PBH in the second half of 2025 following completion of an End-of-Phase 1 meeting with the FDA."

New P2 trial • Hypoglycemia

MBX Biosciences Announces Positive Phase 1 Topline Results for MBX 1416 for the Treatment of Post-bariatric Hypoglycemia (GlobeNewswire) - P1 | N=69 | NCT06036784 | Sponsor: MBX Biosciences | "MBX 1416 was generally well-tolerated with a favorable safety profile. No MBX 1416 dose-related serious adverse events were observed and the majority of treatment-emergent adverse events were mild or moderate in severity. Injection site reactions (ISR), predominantly characterized by erythema, were commonly observed in both single and multiple ascending dose cohorts. These reactions were mild or moderate in 88% of the subjects with ISRs and resolved within approximately seven days in the MAD cohort. MBX 1416 concentrations increased dose-proportionally in both the SAD and MAD cohorts. In the MAD cohort, MBX 1416 median half-life was approximately 90 hours, supporting once-weekly administration, and at steady state the median Tmax was between 36 and 48 hours....MBX Biosciences intends to discuss these results with the U.S. Food and Drug Administration (FDA) in an End-of-Phase 1 meeting in mid-2025."

FDA event • P1 data • Hypoglycemia

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of MBX 1416 in Healthy Subjects (clinicaltrials.gov) - P1 | N=69 | Completed | Sponsor: MBX Biosciences | Active, not recruiting ➔ Completed

Trial completion • Hypoglycemia

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of MBX 1416 in Healthy Subjects (clinicaltrials.gov) - P1 | N=84 | Active, not recruiting | Sponsor: MBX Biosciences | Recruiting ➔ Active, not recruiting

Enrollment closed • Hypoglycemia

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of MBX 1416 in Healthy Subjects (clinicaltrials.gov) - P1 | N=84 | Recruiting | Sponsor: MBX Biosciences | Phase classification: P1/2 ➔ P1 | N=56 ➔ 84

Enrollment change • Phase classification • Hypoglycemia

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of MBX 1416 in Healthy Subjects and Patients With Postbariatric Hypoglycemia (clinicaltrials.gov) - P1/2 | N=56 | Recruiting | Sponsor: MBX Biosciences | Not yet recruiting ➔ Recruiting

Enrollment open • Hypoglycemia

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of MBX 1416 in Healthy Subjects and Patients With Postbariatric Hypoglycemia (clinicaltrials.gov) - P1/2 | N=56 | Not yet recruiting | Sponsor: MBX Biosciences

New P1/2 trial • Hypoglycemia