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 developed by Novo Nordisk A/S for metabolic conditions. It is being studied in type 2 diabetes, obesity, and overweight. It is not approved and remains in clinical development, with Phase 2 trials currently recruiting.
UBT251 targets the GLP-1, GIP, and GCG receptors, a triple receptor agonist profile. By acting on these three receptors, it is designed to influence metabolic pathways relevant to blood sugar control and body weight. Novo Nordisk is developing it as a small molecule for type 2 diabetes, obesity, and overweight.
Novo Nordisk A/S develops UBT251. The company trades under the ticker NVO. Novo Nordisk is running the clinical program, which includes Phase 1 and Phase 2 studies in the United States, Canada, Europe, Australia, and South Korea.
UBT251 is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. The Phase 2 program includes a type 2 diabetes study and an overweight or obesity study, both currently recruiting, alongside two Phase 1 drug interaction studies.
UBT251 is being studied in four recruiting trials. NCT07668388 is a Phase 2 type 2 diabetes study enrolling 300 participants, and NCT07395687 is a Phase 2 overweight or obesity study enrolling 333. Phase 1 studies NCT07710768 and NCT07710729 each enroll about 40 participants.
UBT251 is being evaluated in type 2 diabetes as an investigational treatment to lower blood sugar. The Phase 2 trial NCT07668388 compares different doses of UBT251 in adults with type 2 diabetes across sites in the United States, Australia, Germany, Hungary, Poland, Romania, Slovakia, South Korea, and Spain.