Postbariatric HypoglycemiaPhase 2NCT07029412
Study to Evaluate Efficacy and Dose Response of Imapextide (STEADI)
A Phase 2 study testing MBX 1416 (INN imapextide) in people with Postbariatric Hypoglycemia, run by MBX Biosciences at 4 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postbariatric Hypoglycemia
- What is being tested?
- MBX 1416 (INN imapextide)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Aug 2025to 1 May 2026
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
MBX Biosciences Investigational Site
Aurora, Colorado, 80045
MBX Biosciences Investigational Site
Knoxville, Tennessee, 37920
MBX Biosciences Investigational Site
Morehead City, North Carolina, 28557
MBX Biosciences Investigational Site
San Antonio, Texas, 78229
About this study
Official title: A Phase 2a, Open-label, Exploratory Study to Evaluate Preliminary Efficacy of Subcutaneous MBX 1416 in Patients With Postbariatric Hypoglycemia (The STEADI Study)
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
Read the detailed description
This is a Phase 2a, open-label, exploratory study to evaluate preliminary efficacy of SC MBX 1416 in patients with PBH. Approximately 20 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
- Being tested
- MBX 1416 (INN imapextide)
- Keywords
- PBH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBX 1416 (INN imapextide)Drug
A single subcutaneous injection of MBX 1416 at a low dose and a high dose approximately 2 weeks apart.
| Study group | Role | What they receive |
|---|---|---|
| MBX 1416 (INN imapextide) | Experimental | Single subcutaneous administration at different dose levels Receives: Drug: MBX 1416 (INN imapextide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline to post-treatment in glucose nadir during a standardized MMTT following different dose levels of MBX 1416.
Measured: The duration of the study will be approximately 67 days from screening to end of study (EoS) for any given participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start26 Aug 2025
- Primary completion18 Apr 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postbariatric HypoglycemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT07029412
- Sponsor's protocol ID
- MBX-1P2002
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2025
- Last updated
- 2 Jul 2026
- 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 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Open-label, Exploratory Study to Evaluate Preliminary Efficacy of Subcutaneous MBX 1416 in Patients With Postbariatric Hypoglycemia (The STEADI Study)
- ClinicalTrials.gov ID
- NCT07029412
- Acronym / sponsor ID
- MBX-1P2002
- Conditions
- Postbariatric Hypoglycemia
- Keywords
- PBH
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- MBX BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- 18 Apr 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 19 Jun 2025 (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.
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 20 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MBX 1416 (INN imapextide) | Experimental | Drug: MBX 1416 (INN imapextide)Single subcutaneous administration at different dose levels |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
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 1416 (INN imapextide)A single subcutaneous injection of MBX 1416 at a low dose and a high dose approximately 2 weeks apart. | Drug | MBX 1416 (INN imapextide) |
Primary outcome
Changes from baseline to post-treatment in glucose nadir during a standardized MMTT following different dose levels of MBX 1416.
Time frame: The duration of the study will be approximately 67 days from screening to end of study (EoS) for any given participant
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 2 Jul 2026.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MBX 1416 (INN imapextide) in people with Postbariatric Hypoglycemia, run by MBX Biosciences at 4 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 6 inclusion and 4 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 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Changes from baseline to post-treatment in glucose nadir during a standardized MMTT following different dose levels of MBX 1416. (time frame: The duration of the study will be approximately 67 days from screening to end of study (EoS) for any given participant). 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 2 Jul 2026.