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

NCT07029412 | Completed Phase 2 FDA Drug

• 1 other identifier: MBX-1P2002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

Brief 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

Conditions

Postbariatric Hypoglycemia

Keywords

PBH

Outcome Measures

Primary Outcomes (1)

• Changes from baseline to post-treatment in glucose nadir during a standardized MMTT following different dose levels of MBX 1416.

  The duration of the study will be approximately 67 days from screening to end of study (EoS) for any given participant

Study Arms (1)

MBX 1416 (INN imapextide)

EXPERIMENTAL

Single subcutaneous administration at different dose levels

Drug: MBX 1416 (INN imapextide)

Interventions

MBX 1416 (INN imapextide) DRUG

A single subcutaneous injection of MBX 1416 at a low dose and a high dose approximately 2 weeks apart.

MBX 1416 (INN imapextide)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be ≥18 to ≤75 years of age at the time of signing the informed consent.
• Participants must have undergone RYGB or SG surgery at least 12 months prior to study entry.
• Participants should have a documented history of PBH, defined as Whipple's triad (symptomatic hypoglycemia, capillary glucose ≤54 mg/dL, with symptom resolution by carbohydrate administration) and a minimum of 1 symptomatic hypoglycemic episode per month by patient report.
• Participants who are either treatment naïve or who are no longer using (i.e., have discontinued as part of their usual medical care) agents known to interfere with glucose metabolism at the time of screening.
• Participants must have a body mass index (BMI) \<45 kg/m2 at screening.
• Must have signed informed consent.

You may not qualify if:

• History of, or currently active, significant illness or medical disorders that in the opinion of the investigator may preclude participants from participating in the study.
• Currently on-going type II diabetes mellitus.
• History of hypoglycemia prior to bariatric surgery.
• History of insulinoma or other endogenous hyperinsulinemia illness (e.g., congenital hyperinsulinism).

Sponsors & Collaborators

• MBX Biosciences: lead

Study Sites (4)

MBX Biosciences Investigational Site

Aurora, Colorado, 80045, United States

Location

MBX Biosciences Investigational Site

Morehead City, North Carolina, 28557, United States

Location

MBX Biosciences Investigational Site

Knoxville, Tennessee, 37920, United States

Location

MBX Biosciences Investigational Site

San Antonio, Texas, 78229, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start: August 26, 2025
• Primary Completion: April 18, 2026
• Study Completion: May 1, 2026
• Last Updated: July 2, 2026

Record last verified: 2026-06

Locations

US (4)