64 Participants Needed

MBX 4291 for Obesity

EF
SH
Overseen ByStewart Hallett
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: MBX Biosciences

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MBX 4291 to determine its safety and tolerability for people with obesity. Researchers will compare MBX 4291 to a placebo (a harmless pill with no effect) across different groups to identify any side effects. The trial targets adults with obesity (BMI between 30 and 40) whose weight has remained stable for the past three months. Participants should not have conditions like diabetes or specific thyroid issues. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that MBX 4291 is likely to be safe for humans?

Research has shown that MBX 4291 appears promising in early lab studies. These studies suggest the treatment might aid in weight loss and could be safe for monthly use. However, this trial is in its initial stages, meaning limited information exists about the safety of MBX 4291 for humans. Early trials like this primarily focus on assessing a treatment's safety, so more details will emerge as the study progresses.12345

Why do researchers think this study treatment might be promising?

Most treatments for obesity focus on lifestyle changes, medications that decrease appetite, or surgery. But MBX 4291 works differently, targeting the underlying biological processes that contribute to obesity. Unlike traditional approaches, MBX 4291 is designed to adjust metabolic pathways, potentially offering a more direct method of weight management. Researchers are excited about this because it could offer a new way to treat obesity that doesn't rely solely on altering diet or exercise patterns. This innovative approach might also lead to more sustainable weight loss results.

What evidence suggests that MBX 4291 might be an effective treatment for obesity?

Research suggests that MBX 4291, which participants in this trial may receive, might aid weight loss in people with obesity. Early studies show it works similarly to some approved drugs that affect hormones controlling hunger and insulin. MBX 4291 is designed for monthly administration, potentially offering more convenience than more frequent treatments. Initial results indicate it could assist with weight loss and is generally well-tolerated. However, these findings are from early studies, and further research is necessary to confirm its effectiveness in people.12356

Are You a Good Fit for This Trial?

This trial is for adults with obesity, which may include those who have struggled with weight since childhood. Participants must meet certain health criteria to join.

Inclusion Criteria

Weight-stable, i.e., no more than ±5% change in body weight for at least 3 months prior to screening and between screening and baseline.
I am between 18 and 65 years old.
My BMI is between 30 and 40.

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 or someone in my family has had medullary thyroid cancer or MEN2.
My obesity is not caused by specific genetic or hormonal conditions.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Single Ascending Dose (SAD)

Participants receive single ascending doses of MBX 4291 or placebo

4 weeks

Treatment - Multiple Ascending Dose (MAD)

Participants receive multiple ascending doses of MBX 4291 or placebo

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • MBX 4291
Trial Overview The study tests MBX 4291, a new potential treatment for obesity. It involves comparing the effects of this drug against a placebo when given as subcutaneous injections.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: MBX 4291 (Part B)Experimental Treatment1 Intervention
Group II: MBX 4291 (Part A)Experimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

MBX Biosciences

Lead Sponsor

Trials
5
Recruited
290+

Citations

NCT07142707 | A Study to Evaluate the Safety, Tolerability ...The purpose of this study is to evaluate the safety and tolerability of single and multiple subcutaneous (SC) doses of MBX 4291 in adults with ...
MBX Biosciences Doses First Participant in Phase 1 Trial of ...Preclinical data support the potential for improved weight loss and tolerability with once-monthly administration of MBX 4291.
MBX Biosciences Announces IND Submission of ...Preclinical data suggest MBX 4291 exhibits a similar activity profile and weight loss effect as the currently approved weekly GLP-1/GIP co- ...
MBX Biosciences Reports Third Quarter 2025 Financial ...MBX 4291. Q4 2026: Results from 12-week multiple ascending dose portion of Phase 1 trial of MBX 4291 for the treatment of obesity. Imapextide.
MBX-4291 - Drug Targets, Indications, PatentsAnother drug, nicknamed MBX 4291, entered Phase 1 for obesity earlier this month. The biotech hopes MBX 4291 could compete in the obesity drug market as a once- ...
MBX Biosciences Doses First Participant in Phase 1 Trial of ...Preclinical data support the potential for improved weight loss and tolerability with once-monthly administration of MBX 4291.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security