Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
UBT251 · 4 trials · 3 indications
Measured as percentage (%)-point.
Measured as Number of events.
Measured as percentage of body weight.
Measured as hour\*nanomoles per liter (h\*nmol/L)
Measured in hours picograms per millilitre (h\*pg/mL).
Measured in h\*pg/mL.
Measured in nanogram hour per millilitre (ng\*h/mL).
Measured in ng\*h/mL.
Measured in ng\*h/mL.
| Arm | Type | Description |
|---|---|---|
| UBT251 | EXPERIMENTAL | Participants will receive once weekly UBT251 subcutaneously. |
| UBT251 Placebo | PLACEBO_COMPARATOR | Participants will receive once weekly UBT251 placebo subcutaneously. |
| Semaglutide | ACTIVE_COMPARATOR | Participants will receive once weekly semaglutide subcutaneously. |
| Semaglutide Placebo | PLACEBO_COMPARATOR | Participants will receive once weekly semaglutide placebo subcutaneously. |
| Part A - UBT251 | EXPERIMENTAL | Participants will be randomized to receive multiple dose levels subcutaneously. |
| Part A - placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to UBT251 subcutaneously. |
| Part B - Arm A (UBT251) | EXPERIMENTAL | Participants will be randomized to receive multiple dose levels subcutaneously. |
| Part B - Arm B (UBT251) | EXPERIMENTAL | Participants will be randomized to receive multiple dose levels subcutaneously. |
| Part B - Arm C (UBT251) | EXPERIMENTAL | Participants will be randomized to receive multiple dose levels subcutaneously. |
| Part B - Arm D (UBT251) | EXPERIMENTAL | Participants will be randomized to receive 2 dose levels subcutaneously. |
| Part B - Arm E (UBT251) | EXPERIMENTAL | Participants will be randomized to receive a single dose level subcutaneously. |
| Part B - placebo | PLACEBO_COMPARATOR | Participants will receive placebo matching one of the UBT251 arms subcutaneously. |
| Part C - UBT251 dose 1 | EXPERIMENTAL | Participants will be randomized to receive dose level 1 subcutaneously. |
| Part C - UBT251 dose 2 | EXPERIMENTAL | Participants will be randomized to receive dose level 2 subcutaneously. |
| Part C - UBT251 dose 3 | EXPERIMENTAL | Participants will be randomized to receive dose level 3 subcutaneously. |
| Oral Contraceptive (ethinylestradiol [EE] and levonorgestrel [LN]) | EXPERIMENTAL | An oral contraceptive will be administered during baseline and treatment assessment periods to evaluate the effect of UBT251 on oral contraceptive pharmacokinetics. |
| Acetaminophen (equivalent to paracetamol [para]) | EXPERIMENTAL | A single dose of acetaminophen will be administered with a standardised meal during baseline and treatment assessment periods to evaluate gastric emptying |
| Cocktail (Warfarin/Caffeine/Midazolam) | EXPERIMENTAL | A cocktail containing warfarin, caffeine, and midazolam will be administered at predefined study visits to evaluate the effect of UBT251 on the pharmacokinetics of CYP enzyme substrates. |
| Name | Type | Description |
|---|---|---|
| UBT251 | DRUG | UBT251 will be administered subcutaneously once-weekly. |
| UBT251 Placebo | DRUG | UBT251 placebo will be administered subcutaneously once-weekly. |
| Semaglutide | DRUG | Semaglutide will be administered subcutaneously once-weekly. |
| Semaglutide Placebo | DRUG | Semaglutide placebo will be administered subcutaneously once-weekly. |
| Placebo | DRUG | Placebo matched to UBT251 injection will be administered subcutaneously in a lifted fold of the abdominal skin. |
| Oral contraceptive | DRUG | Administered orally. |
| Acetaminophen | DRUG | Administered orally. |
| Cocktail (Warfarin/Caffeine/Midazolam) | DRUG | Administered orally. |
Inclusion Criteria: * Male or female (sex assigned at birth, inclusive of all gender identities). * Age 18-75 years (both inclusive) at the time of signing the informed consent. * Diagnosed with type 2 diabetes greater than or equal to (≥) 180 days before screening. * Stable daily dose(s) ≥ 90 days...
UBT251 is an investigational small molecule being developed for metabolic conditions, specifically Type 2 diabetes, overweight, and obesity. It is currently in Phase 2 clinical trials and is not yet approved by regulatory authorities.
UBT251 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker symbol NVO. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
UBT251 is currently in Phase 2 clinical development. Two Phase 2 trials are recruiting participants, one for overweight or obesity and another for Type 2 diabetes. The drug is investigational and has not received regulatory approval.
UBT251 is being studied in two Phase 2 trials: NCT07395687 for overweight or obesity and NCT07668388 for Type 2 diabetes. Both trials are recruiting and are randomized, double-blind, and placebo-controlled.
UBT251 is the primary name used in clinical trials and research. No alternative names have been reported for this investigational drug, which is being developed by Novo Nordisk for metabolic conditions.