Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as UBT251
UBT251 group · 2 trials · 1 indication
Change in HbA1c from Baseline
| Arm | Type | Description |
|---|---|---|
| UBT251 Injection 2.0 mg | EXPERIMENTAL | Each subject will receive UBT251 Injection s.c. once weekly for 36 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 36 weeks. |
| UBT251 Injection 4.0 mg | EXPERIMENTAL | Each subject will receive UBT251 Injection, s.c. once weekly for 36 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 36 weeks. |
| UBT251 Injection 6.0 mg | EXPERIMENTAL | Each subject will receive UBT251 Injection s.c. once weekly for 36 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 36 weeks. |
| UBT251 Injection Placebo 2.0 mg | PLACEBO_COMPARATOR | Each subject will receive UBT251 Injection Placebo, s.c. once weekly for 36 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 36 weeks. |
| UBT251 Injection Placebo 4.0 mg | PLACEBO_COMPARATOR | Each subject will receive UBT251 Injection Placebo, s.c. once weekly for 36 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 36 weeks. |
| UBT251 Injection Placebo 6.0 mg | PLACEBO_COMPARATOR | Each subject will receive UBT251 Injection Placebo, s.c. once weekly for 36 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 36 weeks. |
| UBT251 Injection 2.0mg group | EXPERIMENTAL | Each participants 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 4.0mg group | EXPERIMENTAL | Each participants 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 6.0mg group | EXPERIMENTAL | Each participants 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. |
| Semaglutide Injection 1mg group | ACTIVE_COMPARATOR | S.C. once weekly |
| Name | Type | Description |
|---|---|---|
| UBT251 Injection 2.0 mg | DRUG | UBT251 Injection subcutaneously once weekly |
| UBT251 Injection 4.0 mg | DRUG | UBT251 Injection subcutaneously once weekly |
| UBT251 Injection 6.0 mg | DRUG | UBT251 Injection subcutaneously once weekly |
| UBT251 Injection Placebo 2.0 mg | DRUG | 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 Injection 2.0 mg group | DRUG | UBT251 Injection subcutaneously once weekly |
| UBT251 Injection 4.0 mg group | DRUG | UBT251 Injection subcutaneously once weekly |
| UBT251 Injection 6.0 mg group | DRUG | UBT251 Injection subcutaneously once weekly |
| Semaglutide Injection | DRUG | Semaglutide Injection subcutaneously once weekly |
Inclusion Criteria: 1. Aged 18-75 years (inclusive) at the time of signing the informed consent form (ICF), regardless of gender; 2. Diagnosed with type 2 diabetes mellitus (T2DM) for at least 3 months in accordance with the 2019 World Health Organization (WHO) criteria; 3. Managed solely through d...
Top 20 of 31 competitors
UBT251 is an investigational small molecule being developed for metabolic conditions, including Type 2 Diabetes, Obesity & Overweight, and Metabolic Dysfunction-associated Steatohepatitis (MASH). It is currently in clinical development and has not been approved by regulatory authorities.
UBT251 is being developed by United Therapeutics Corporation, a publicly traded company listed on NASDAQ under the ticker symbol UTHR. The company is conducting clinical trials for this investigational metabolic drug candidate.
UBT251 is in Phase 2 clinical development for Metabolic Dysfunction-associated Steatohepatitis (MASH), with a recruiting Phase 2 trial. Additionally, Phase 3 trials have been registered for obesity and Type 2 Diabetes, though these have not yet started recruiting.
UBT251 has four registered trials. NCT07145151 is a Phase 2 study in MASH. NCT07648225 is a Phase 3 obesity trial. NCT07653477 and NCT07659574 are Phase 3 studies in Type 2 Diabetes, with the latter two not yet recruiting.
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.