MBX 1416 for Post-Bariatric Hypoglycemia

Recruiting at 3 trial locations

Overseen By Stewart Hallett

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: MBX Biosciences

Must not be taking: Glucose metabolism agents

Disqualifiers: Type II diabetes, Insulinoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 week

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, MBX 1416, for individuals experiencing low blood sugar (hypoglycemia) after certain types of weight-loss surgery. The goal is to evaluate the treatment's effectiveness when administered once under the skin at two different dose levels. Suitable candidates have undergone gastric bypass or sleeve surgery at least a year ago and regularly experience low blood sugar episodes that improve with carbohydrate intake. Individuals with ongoing type II diabetes or certain other medical conditions are ineligible. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial requires that participants are either not currently using or have already stopped using medications that affect glucose metabolism. If you're on such medications, you may need to stop them before joining the study.

Is there any evidence suggesting that MBX 1416 is likely to be safe for humans?

A previous study tested MBX 1416 on healthy volunteers, and it was generally well-tolerated, meaning most participants did not experience serious side effects. The study showed that MBX 1416 was safe for humans. Researchers closely monitored participants for any negative reactions, and the results were positive. This treatment is now under investigation in patients with low blood sugar after weight-loss surgery to assess its effectiveness for them as well. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for post-bariatric hypoglycemia, which often involve dietary changes and medications to manage blood sugar levels, MBX 1416 introduces a novel approach. It utilizes a new active ingredient called imapextide, administered subcutaneously, that could offer more precise control over hypoglycemia. Researchers are excited because this method targets the condition more directly, potentially providing quicker and more effective relief from symptoms than current options.

What evidence suggests that MBX 1416 might be an effective treatment for post-bariatric hypoglycemia?

Research shows that MBX 1416, which participants in this trial will receive, might help treat low blood sugar after weight-loss surgery, known as post-bariatric hypoglycemia (PBH). Earlier studies found that people generally tolerated MBX 1416 well, and it was considered safe. It appears to work by affecting GLP-1, a hormone that helps control blood sugar, suggesting it could help manage low blood sugar after surgery. Although data on its effectiveness for PBH is limited, its impact on GLP-1 is encouraging. Early results are promising, but further research is needed to confirm these findings. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals who have developed low blood sugar levels (hypoglycemia) after undergoing weight loss surgery (bariatric surgery). Specific eligibility details are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.

Inclusion Criteria

I haven't taken or have stopped taking medications that affect blood sugar for my condition.

I had gastric bypass or sleeve gastrectomy surgery over a year ago.

I experience at least one episode of low blood sugar each month that gets better after eating carbs.

Exclusion Criteria

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

I am currently being treated for type II diabetes.

I had low blood sugar episodes before my weight loss surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo a mixed-meal tolerance test at baseline

1 day

1 visit (in-person)

Treatment

Single subcutaneous administration of MBX 1416 at 2 different dose levels, followed by mixed-meal tolerance tests 48 hours post-administration

1 week

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MBX 1416

Trial Overview

The study is testing the effectiveness of a medication called MBX 1416, administered under the skin at two different doses, in patients experiencing hypoglycemia following bariatric surgery. The goal is to see if this drug can help manage their blood sugar levels.

How Is the Trial Designed?

Group I: MBX 1416 (INN imapextide) Experimental Treatment 1 Intervention

Single subcutaneous administration at different dose levels

Who Is Running the Clinical Trial?

MBX Biosciences

Lead Sponsor

Trials

5

Recruited

290+

Citations

1.

investors.mbxbio.com

investors.mbxbio.com/news-releases/news-release-details/mbx-biosciences-announces-positive-phase-1-topline-results-mbx

MBX Biosciences Announces Positive Phase 1 Topline ...

Phase 1 trial in healthy volunteers showed MBX 1416 was generally well-tolerated with a favorable safety profile. Pharmacokinetic results demonstrated ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07029412

NCT07029412 | Study to Evaluate Efficacy and Dose ...

... Efficacy of Subcutaneous MBX 1416 in Patients With Postbariatric Hypoglycemia (The STEADI Study) ... History of hypoglycemia prior to bariatric surgery.

3.

diabetesjournals.org

diabetesjournals.org/diabetes/article/74/Supplement_1/846-P/159930/846-P-Safety-and-Pharmacokinetics-of-MBX-1416-a

846-P: Safety and Pharmacokinetics of MBX 1416, a ...

Conclusion: In HVs, MBX 1416 was generally well tolerated, with PK supporting weekly dosing, PD showing an apparent effect on GLP-1, and minimal ...

4.

drug-dev.com

drug-dev.com/mbx-biosciences-announces-positive-phase-1-topline-results-for-post-bariatric-hypoglycemia-treatment/

MBX Biosciences Announces Positive Phase 1 Topline ...

MBX Biosciences Announces Positive Phase 1 Topline Results for Post-Bariatric Hypoglycemia Treatment · MBX 1416 was generally well-tolerated with a favorable ...

5.

firstwordpharma.com

firstwordpharma.com/story/6517808

MBX Biosciences Reports Third Quarter 2025 Financial ...

Results from the planned 12-week MAD portion are expected in Q4 2026. Post-bariatric Hypoglycemia (PBH): Imapextide (MBX 1416). Dosed first ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06036784

Study Details | NCT06036784 | Safety, Tolerability, ...

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of MBX 1416 in Healthy Subjects. ClinicalTrials.gov ID NCT06036784. Sponsor MBX Biosciences.

7.

withpower.com

withpower.com/trial/phase-2-hypoglycemia-7-2025-e8168

MBX 1416 for Post-Bariatric Hypoglycemia

Prior Safety DataThis treatment has passed at least one previous human trial ... Participants are monitored for safety and effectiveness after treatment. 4 ...

8.

firstwordpharma.com

firstwordpharma.com/story/5987279

MBX Biosciences Reports Second Quarter 2025 Financial ...

Imapextide (MBX 1416) Phase 2a trial initiation in patients with post-bariatric hypoglycemia anticipated in Q3 2025. MBX 4291 Phase 1 trial ...