Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zenagamtide · 3 trials · 2 indications
Measured as percentage of body weight.
| 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. |
| 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. |
| 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. |
| Placebo | DRUG | Placebo matched to zenagamtide will be taken orally. |
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...
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Zenagamtide is an investigational small molecule being developed for the treatment of obesity and overweight. It is currently in Phase 3 clinical trials, which are designed to evaluate its effectiveness in helping people with excess body weight lose weight.
Zenagamtide 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 Phase 3 clinical trials to investigate the drug's efficacy in treating obesity and overweight.
Zenagamtide is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 3 trials are designed to assess its safety and efficacy in treating obesity and overweight.
Zenagamtide is being studied in three Phase 3 clinical trials: NCT07668401 (AMAZE 13) in Asia, NCT07668414 comparing it to semaglutide in the United States, and NCT07720271 (AMAZE 9) in the United States. These trials are not yet recruiting and have a combined enrollment of approximately 1,600 participants.
Zenagamtide is not the same as semaglutide. It is a distinct investigational drug being developed by Novo Nordisk. One of its Phase 3 clinical trials (NCT07668414) is specifically designed to compare Zenagamtide against semaglutide to evaluate how well it helps people with excess body weight lose weight.