Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as UBT251 group
UBT251 · 3 trials · 4 indications
Percentage change in body weight from baseline after 52 weeks of treatment
The change in log-transformed UACR from baseline after 24 weeks of treatment
| Arm | Type | Description |
|---|---|---|
| UBT251 Injection 4.0 mg | EXPERIMENTAL | Each subject will receive UBT251 Injection s.c. once weekly for 52 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 52 weeks. |
| UBT251 Injection 6.0 mg | EXPERIMENTAL | Each subject will receive UBT251 Injection, s.c. once weekly for 52 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 52 weeks. |
| UBT251 Injection Placebo 4.0 mg | PLACEBO_COMPARATOR | Each subject will receive UBT251 Injection Placebo, s.c. once weekly for 52 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 52 weeks. |
| UBT251 Injection Placebo 6.0 mg | PLACEBO_COMPARATOR | Each subject will receive UBT251 Injection Placebo, s.c. once weekly for 52 weeks. Each dose group will be titrated starting from the initial dose, administered once weekly, and escalated to the next dose after 4 weeks until the target maintenance dose is reached, with a total treatment duration of 52 weeks. |
| UBT251 Low Dose | EXPERIMENTAL | Dose level 1,SC, once a week for 4 weeks; Dose level 2,SC, once a week for 4 weeks; Dose level 3,SC,once a week for 4 weeks; Dose level 3,SC, once a week for 36 weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo administered subcutaneously (SC) once a week for 48 weeks. |
| UBT251 Middle Dose | EXPERIMENTAL | Dose level 2,SC, once a week for 4 weeks; Dose level 3,SC, once a week for 4 weeks; Dose level 4,SC,once a week for 4 weeks; Dose level 4,SC, once a week for 36 weeks. |
| UBT251 High Dose | EXPERIMENTAL | Dose level 2,SC, once a week for 4 weeks; Dose level 3,SC, once a week for 4 weeks; Dose level 4,SC,once a week for 4 weeks; Dose level 5,SC, once a week for 36 weeks. |
| 2.0 mg group | EXPERIMENTAL | Patients will be treated with UBT251 s.c. once weekly for 24 weeks. The starting dose of UBT251 will be 0.5 mg subcutaneous injection with increasing doses at 5, 9 and 13 weeks to 1.0, 2.0 and 2.0 mg once weekly. |
| 4.0 mg group | EXPERIMENTAL | Patients will be treated with UBT251 s.c. once weekly for 24 weeks. The starting dose of UBT251 will be 1.0 mg subcutaneous injection with increasing doses at 5, 9 and 13 weeks to 2.0, 4.0 and 4.0 mg once weekly. |
| 6.0 mg group | EXPERIMENTAL | Patients will be treated with UBT251 s.c. once weekly for 24 weeks. The starting dose of UBT251 will be 1.0 mg subcutaneous injection with increasing doses at 5, 9 and 13 weeks to 2.0, 4.0 and 6.0 mg once weekly. |
| Name | Type | Description |
|---|---|---|
| UBT251 Injection 4.0 mg | DRUG | UBT251 Injection subcutaneously once weekly |
| UBT251 Injection 6.0 mg | DRUG | UBT251 Injection and UBT251 Injection Placebo subcutaneously once weekly |
| UBT251 Injection Placebo 4.0 mg | DRUG | UBT251 Injection placebo subcutaneously once weekly |
| UBT251 Injection Placebo 6.0 mg | DRUG | UBT251 Injection placebo subcutaneously once weekly |
| UBT251 | DRUG | UBT251 administered subcutaneously (SC) once a week. |
| Placebo | DRUG | Placebo,SC,once a week for 48 weeks |
Inclusion Criteria： 1. Age 18-75 years (inclusive) at the time of signing the informed consent form, regardless of gender; 2. Body mass index (BMI) ≥28.0 kg/m² (obesity) or 24.0 kg/m² ≤ BMI \<28.0 kg/m² (overweight) at screening, accompanied by by at least one of the following: a. Prediabetes, hype...
UBT251 is an investigational small molecule being developed for metabolic conditions, including Type 2 Diabetes, Obesity and Overweight, and Metabolic Dysfunction-associated Steatohepatitis (MASH). It is also being studied in chronic kidney disease. UBT251 is currently in Phase 2 and Phase 3 clinical trials.
UBT251 is being developed by United Therapeutics Corporation, a publicly traded company with the ticker symbol UTHR. The drug is in clinical development for metabolic indications including Type 2 Diabetes, Obesity and Overweight, and MASH.
UBT251 is in Phase 2 and Phase 3 clinical development. Phase 2 trials are recruiting for obesity with chronic kidney disease and for MASH. Phase 3 trials are planned for overweight or obesity and for Type 2 Diabetes, though those have not yet started recruiting.
UBT251 has four registered trials. NCT07134335 is a Phase 2 study in obesity and chronic kidney disease. NCT07145151 is a Phase 2 study in MASH. NCT07648225 is a Phase 3 study in overweight or obesity. NCT07653477 is a Phase 3 study in Type 2 Diabetes.
Yes, UBT251 is also known as UBT251 Injection 4.0 mg, UBT251 Injection 2.0 mg, and UBT251 Injection 2.0 mg group. These names refer to the same investigational drug product in different dosage forms or study groups.
UBT251 is not FDA approved. It is an investigational drug currently in clinical trials. The drug is being studied in Phase 2 and Phase 3 trials for metabolic conditions, but approval status has not been established.