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MBX 1416 for Post-Surgery Low Blood Sugar

Phase 1

Recruiting

Research Sponsored by MBX Biosciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through day 29 (part a) or day 45 (part b) and day 21 (part c)

Awards & highlights

Study Summary

This trial tests a potential new drug to treat postbariatric hypoglycemia in healthy people and patients. It will assess safety, how the body processes the drug, and its effectiveness.

Who is the study for?

This trial is for adults aged 18-65 with stable weight and normal blood sugar levels. It's specifically for those who've had bariatric surgery at least 6 months ago and are experiencing low blood sugar after the procedure. People with a history of serious reactions to GLP-1 receptor agonists, other causes of hypoglycemia, or certain health conditions like pancreatitis aren't eligible.Check my eligibility

What is being tested?

The study tests MBX 1416, a drug given by injection under the skin (subcutaneous), in two parts: Part A gives one dose; Part B gives multiple doses. The effects on safety, how well it's tolerated, its movement through and impact on the body compared to a placebo are being studied.See study design

What are the potential side effects?

While specific side effects for MBX 1416 aren't listed here, similar drugs can cause reactions at the injection site, digestive issues, allergic responses like angioedema (swelling beneath the skin), and potentially affect heart rhythm or lab test results.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through day 29 (part a) or day 45 (part b) and day 21 (part c)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through day 29 (part a) or day 45 (part b) and day 21 (part c)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through day 29 (part a) or day 45 (part b) and day 21 (part c) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Plasma Concentration (Cmax)

Number of participants with adverse events (AEs), Serious Adverse Events (SAEs)

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: MBX 1416 (Part C)Experimental Treatment1 Intervention

Single subcutaneous (SC) dose of MBX 1416, single dose of rosuvastatin and acetaminophen.

Group II: MBX 1416 (Part B)Experimental Treatment1 Intervention

Repeated ascending subcutaneous (SC) doses

Group III: MBX 1416 (Part A)Experimental Treatment1 Intervention

Single ascending subcutaneous (SC) doses

Group IV: PlaceboPlacebo Group1 Intervention

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

MBX BiosciencesLead Sponsor

1 Previous Clinical Trials

76 Total Patients Enrolled

ProSciento, Inc.Industry Sponsor

5 Previous Clinical Trials

234 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently involved in this research endeavor?

"Indeed, the details available on clinicaltrials.gov indicate that this medical experiment is now actively searching for volunteers to join. This investigation was posted on September 18th 2023 and last revised November 13th 2023; it requires 56 test subjects at 1 site."

Answered by AI

Is this research accepting participants aged 20 or older?

"This medical research is looking for individuals aged between 18 and 65 years old."

Answered by AI

Is this research endeavor looking for new participants presently?

"The information on clinicaltrials.gov indicates that this experiment is actively seeking participants. First posted on September 18th 2023, the trial has been recently modified as of November 13th 2023."

Answered by AI

What criteria must individuals meet in order to be qualified for enrollment in this medical experiment?

"This clinical trial requires 56 volunteers, all of whom must meet certain criteria such as a fasting plasma glucose level below 100 mg/dL and an HbA1c lower than 5.7%. As well, the eligible participants ought to be both male and female between 18 and 65 years old inclusive; with a Body Mass Index (BMI) ranging from 18-30 kg/m2 along with having had stable body weight for at least 3 months in order to begin Part A."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of MBX 1416 in Healthy Subjects

2023. "Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of MBX 1416 in Healthy Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06036784.

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