Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Zenagamtide injection
Zenagamtide · 7 trials · 4 indications
Measured as percentage of body weight.
Measured in days.
Measured as percentage (%)-points
Measured as number of events
Measured as nanomoles per liter hourly (h\*nmol/L)
| Arm | Type | Description |
|---|---|---|
| Zenagamtide | EXPERIMENTAL | Participants will be randomized to receive 1 out of 3 different dose levels subcutaneously once weekly. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to Zenagamtide subcutaneously once weekly. |
| Semaglutide dose 1 | ACTIVE_COMPARATOR | Participants will receive semaglutide dose 1 and placebo matched to zenagamtide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
| Semaglutide dose 2 | ACTIVE_COMPARATOR | Participants will receive semaglutide dose 2 and placebo matched to zenagamtide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
| Insulin glargine U-100 | ACTIVE_COMPARATOR | Participants will receive Insulin glargine U-100 subcutaneously once daily to one of the body parts: thigh, abdomen or upper arm. |
| Tirzepatide and Zenagamtide | EXPERIMENTAL | Participants will receive one of the different dose levels of tirzepatide administered once weekly by subcutaneous injection. Following the last maintenance dose of tirzepatide, participants will switch to one of the different dose levels of zenagamtide administered once weekly by subcutaneous injection. |
| Zenagamtide subcutaneous (s.c.) | EXPERIMENTAL | Participants will receive one of the different dose levels of zenagamtide once weekly subcutaneously. |
| Zenagamtide oral | EXPERIMENTAL | Participants will receive oral dose of zenagamtide once daily. |
| Name | Type | Description |
|---|---|---|
| Zenagamtide | DRUG | Zenagamtide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
| Placebo ( matched to Zenagamtide) | DRUG | Placebo matched to Zenagamtide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
| Placebo | DRUG | Placebo will be administered subcutaneously. |
| Semaglutide | DRUG | Semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
| Placebo (matched to semaglutide) | DRUG | Placebo matched to semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
| Placebo (matched to zenagamtide) | DRUG | Placebo matched to zenagamtide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
| Insulin glargine U-100 | DRUG | Insulin glargine U-100 will be administered subcutaneously using SoloSTAR pen-injector to one of the body parts: thigh, abdomen or upper arm (rotation of the injection site within body parts). |
| Tirzepatide | DRUG | Tirzeptide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
| Zenagamtide injection | DRUG | Zenagamtide will be administered to one of the body parts: thigh, abdomen or upper arm |
| Zenagamtide tablet | DRUG | Zenagamtide tablet will be taken in the morning in fasted state. |
Inclusion Criteria: * Male or female (sex assigned at birth, inclusive of all gender identities). * Age 18 years or above at the time of signing the informed consent Exclusion Criteria: * Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening. * Histo...
Top 4 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| BridgeBio Pharma, Inc. | BBIO | 2 | PHASE3 | Acoramidis |
| Kiniksa Pharmaceuticals International, plc Class A | KNSA | 1 | PHASE2 | KPL-387 |
| AstraZeneca PLC | AZN | 3 | PHASE1 | AZD1705 |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX310 |
Zenagamtide is an investigational peptide therapy developed by Novo Nordisk A/S for cardiovascular risk, obesity, overweight, and type 2 diabetes. It is being studied in Phase 3 clinical trials, including a large placebo-controlled cardiovascular outcomes study and a comparison against insulin glargine in type 2 diabetes. Zenagamtide is also known as Zenagamtide injection.
Zenagamtide is being developed to lower blood sugar and body weight in people with type 2 diabetes and to treat overweight and obesity, including in patients with established atherosclerotic cardiovascular disease. These uses are under clinical investigation in Phase 3 trials and are not yet established as approved indications.
Zenagamtide is developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is sponsoring the Phase 1 and Phase 3 studies of Zenagamtide across the United States, Europe, Asia, Latin America, and other regions.
Zenagamtide is in Phase 3 clinical development. Two Phase 3 trials are underway: a placebo-controlled cardiovascular outcomes study in people with atherosclerotic cardiovascular disease and overweight or obesity, and the AMBITION 7 study comparing Zenagamtide with insulin glargine in type 2 diabetes. Zenagamtide is investigational and not approved.
Zenagamtide is being studied in four trials. NCT07861100 is a Phase 3 placebo-controlled cardiovascular study with 8,500 planned participants. NCT07797335 (AMBITION 7) is a Phase 3 comparison with insulin glargine enrolling 1,778 people with type 2 diabetes. NCT07868354 and NCT07815067 are Phase 1 studies in overweight or obesity.
Yes. Zenagamtide injection is another name for Zenagamtide, the investigational peptide developed by Novo Nordisk A/S. Both names refer to the same drug candidate being evaluated in Phase 1 and Phase 3 clinical trials for cardiovascular risk, obesity, overweight, and type 2 diabetes.