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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 obesity.
This is a Phase 1, double-blind, placebo-controlled first-in-human study to evaluate the single ascending doses (SAD) and multiple ascending doses (MAD) of MBX 4291 in participants with obesity, who are otherwise generally healthy. Approximately 124 patients aged 18 to 65 years old will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBX 4291 (Part A) | Experimental | Participants will be administered single ascending doses of MBX 4291, or matching placebo. |
|
| MBX 4291 (Part B) | Experimental | Participants will be administered multiple ascending doses of MBX 4291, or matching placebo. |
|
| MBX 4291 (Part C) | Experimental | Participants will be administered multiple ascending doses of MBX 4291, or matching placebo. |
|
| Placebo | Placebo Comparator | Participants will be administered single or multiple ascending doses of placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBX 4291 | Drug | MBX 4291 will be administered subcutaneously (SC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Treatment Emergent Adverse Events (TEAEs) | The total duration of study participation for each participant including screening, treatment period, follow-up, and end of study visit will be up to 91 days in Part A, up to 99 days in Part B, and up to 148 days in Part C. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisa Fabbrini, MD, PhD | Contact | 844-877-4473 | MBX4291.Clinicaltrials@mbxbio.com | |
| Stewart Hallett | Contact | 844-877-4473 | MBX4291.Clinicaltrials@mbxbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MBX Biosciences Investigational Site | Recruiting | Doral | Florida | 33172 | United States | |
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| Placebo | Drug | Placebo: Placebo will be administered subcutaneously (SC) |
|
| MBX Biosciences Investigational Site |
| Recruiting |
| Lexington |
| Kentucky |
| 40509 |
| United States |
| MBX Biosciences Investigational Site | Recruiting | Kansas City | Missouri | 64114 | United States |
| MBX Biosciences Investigational Site | Recruiting | Knoxville | Tennessee | 37920 | United States |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D001835 | Body Weight |
| D050177 | Overweight |
| D009748 | Nutrition Disorders |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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