NCT07029412

Study to Evaluate Efficacy and Dose Response of Imapextide (STEADI)

A Phase 2a, Open-label, Exploratory Study to Evaluate Preliminary Efficacy of Subcutaneous MBX 1416 in Patients With Postbariatric Hypoglycemia (The STEADI Study)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: MBX Biosciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the preliminary efficacy of single SC administration of MBX 1416 at different dose levels in patients with PBH

Detailed description

This is a Phase 2a, open-label, exploratory study to evaluate preliminary efficacy of SC MBX 1416 in patients with PBH. Approximately 10 patients aged 18 to 75 (inclusive) years with history of hypoglycemia following Roux-en-Y or sleeve gastrectomy will be included in the study. Participants will undergo 3 mixed-meal tolerance tests, one at baseline and again 48 hours after each MBX 1416 administration, to evaluate the effect of MBX 1416 on increasing post-prandial glucose nadir. MBX 1416 effect in reducing post-prandial insulin and C-peptide peaks will also be evaluated

Conditions

• Postbariatric Hypoglycemia

Interventions

Type	Name	Description
DRUG	MBX 1416 (INN imapextide)	A single subcutaneous injection of MBX 1416 at a low dose and a high dose approximately 2 weeks apart.

Timeline

• Start date: 2025-08-26
• Primary completion: 2025-12-22
• Completion: 2026-01-26
• First posted: 2025-06-19
• Last updated: 2025-12-17

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study