Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Maridebart Cafraglutide · 19 trials · 14 indications
Heart Failure events include: hospitalization for HF or urgent HF visits.
Change from baseline in QTcF for maridebart cafraglutide will be the dependent variable for calculation of model-derived placebo-corrected, change from baseline in QTcF after maridebart cafraglutide dosing.
A TEAE was defined as any adverse event (AE) which started on or after the first dose of AMG 133. Clinically significant changes in laboratory safety tests, vital signs and 12-lead electrocardiograms (ECGs) were included as AEs.
| Arm | Type | Description |
|---|---|---|
| Maridebart Cafraglutide Low Dose Q4W | EXPERIMENTAL | Participants who received low dose of maridebart cafraglutide in the parent trial (20210184 \[NCT06858878\]) will continue to receive low dose of maridebart cafraglutide subcutaneously (SC) once in 4 weeks (Q4W). |
| Maridebart Cafraglutide Medium Dose Q4W | EXPERIMENTAL | Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive medium dose of maridebart cafraglutide SC Q4W. |
| Maridebart Cafraglutide Medium dose Q8W | EXPERIMENTAL | Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive medium dose of maridebart cafraglutide SC once in 8 weeks (Q8W). |
| Placebo Q4W (Received Medium Dose Maridebart Cafraglutide in Parent Trial) | PLACEBO_COMPARATOR | Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W. |
| Maridebart Cafraglutide High Dose Q4W | EXPERIMENTAL | Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC Q4W. |
| Maridebart Cafraglutide High Dose Q8W | EXPERIMENTAL | Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC Q8W. |
| Placebo Q4W (Received High Dose Maridebart Cafraglutide in Parent Trial) | PLACEBO_COMPARATOR | Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W. |
| Maridebart Cafraglutide High Dose Q4W (Received Placebo in the Parent Trial) | EXPERIMENTAL | Participants who received placebo in the parent trial will receive high dose of maridebart cafraglutide SC Q4W. Prior to initiating the assigned high dose, participants will undergo a dose-escalation phase gradually increasing doses. |
| Maridebart Cafraglutide Low Dose Q4W(Received Very Low Dose Maridebart Cafraglutide in Parent Trial) | EXPERIMENTAL | Participants who permanently de-escalated to very low dose of maridebart cafraglutide in the parent trial will receive low dose of maridebart cafraglutide SC Q4W. |
| Maridebart Cafraglutide High Dose Q12W | EXPERIMENTAL | Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC once in 12 weeks (Q12W). |
| MariTide Arm 1 | EXPERIMENTAL | Participants will receive maridebart cafraglutide dosing schedule 1 during the treatment period. |
| MariTide Arm 2 | EXPERIMENTAL | Participants will receive maridebart cafraglutide dosing schedule 2 during the treatment period. |
| Maridebart Cafraglutide | EXPERIMENTAL | Participants will receive maridebart cafraglutide subcutaneously (SC). |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo SC. |
| Maridebart Cafraglutide High Dose | EXPERIMENTAL | Participants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks. |
| Maridebart Cafraglutide Medium Dose | EXPERIMENTAL | Participants will receive maridebart cafraglutide medium dose SC for 72 weeks. |
| Maridebart Cafraglutide Low Dose | EXPERIMENTAL | Participants will receive maridebart cafraglutide low dose SC for 72 weeks. |
| Cohort A: Maridebart Cafraglutide | EXPERIMENTAL | Part 1: Cohort A will consist of participants without a diagnosis of type 1 or type 2 diabetes mellitus. Participants will be randomized to receive maridebart cafraglutide or placebo in 1 of 7 dose cohorts. Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive maridebart cafraglutide or Placebo in 1 of 4 dose cohorts. |
| Cohort A: Placebo | PLACEBO_COMPARATOR | Part 1: Cohort A will consist of participants without a diagnosis of type 1 or type 2 diabetes mellitus. Participants will be randomized to receive maridebart cafraglutide or placebo in 1 of 7 dose cohorts . Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive maridebart cafraglutide or Placebo in 1 of 4 dose cohorts. |
| Cohort B: Maridebart Cafraglutide | EXPERIMENTAL | Part 1: Cohort B will consist of participants with a diagnosis of type 2 diabetes mellitus. Participants will be randomized to receive maridebart cafraglutide or placebo in 1 of 4 dose cohorts. Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive maridebart cafraglutide or Placebo in 1 of 4 dose cohorts. |
| Cohort B: Placebo | PLACEBO_COMPARATOR | Part 1: Cohort B will consist of participants with a diagnosis of type 2 diabetes mellitus. Participants will be randomized to receive maridebart cafraglutide or placebo in 1 of 4 dose cohorts. Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive maridebart cafraglutide or Placebo in 1 of 4 dose cohorts. |
| Maridebart Cafraglutide SC Presentation 1 | EXPERIMENTAL | Participants will receive a single dose of maridebart cafraglutide administered using SC presentation 1. |
| Maridebart Cafraglutide SC Presentation 2 | ACTIVE_COMPARATOR | Participants will receive a single dose of maridebart cafraglutide administered using SC presentation 2. |
| Group 1 | EXPERIMENTAL | In treatment period 1, participants will receive placebo for moxifloxacin. In treatment period 2, participants will receive maridebart cafraglutide. In treatment period 3, participants will receive placebo for moxifloxacin. |
| Group 2A | EXPERIMENTAL | In treatment period 1, participants will receive moxifloxacin. In treatment period 2, participants will receive placebo for maridebart cafraglutide. In treatment period 3, participants will receive placebo for moxifloxacin. |
| Group 2B | EXPERIMENTAL | In treatment period 1, participants will receive placebo for moxifloxacin. In treatment period 2, participants will receive placebo for maridebart cafraglutide. In treatment period 3, participants will receive moxifloxacin. |
| Group 1: Maridebart Cafraglutide Dose 1 | EXPERIMENTAL | Participants will receive a single SC lower dose of Maridebart Cafraglutide. |
| Group 2: Maridebart Cafraglutide Dose 2 | EXPERIMENTAL | Participants will receive a single SC higher dose of Maridebart Cafraglutide. |
| Part A: maridebart cafraglutide | EXPERIMENTAL | Up to 7 single ascending dose cohorts (cohorts 1 to 6 and cohort 11). |
| Part A: Placebo | PLACEBO_COMPARATOR | Up to 7 single ascending dose cohorts (cohorts 1 to 6 and cohort 11). |
| Part B: maridebart cafraglutide | EXPERIMENTAL | Up to 4 multiple ascending dose cohorts (cohorts 7 to 10). |
| Part B: Placebo | PLACEBO_COMPARATOR | Up to 4 multiple ascending dose cohorts (cohorts 7 to 10). |
| Part C: maridebart cafraglutide | EXPERIMENTAL | Up to 2 open-label, multiple ascending dose cohorts (cohorts 12 to 13) treated with doses previously studied in Part A and Part B. |
| Name | Type | Description |
|---|---|---|
| Maridebart Cafraglutide | DRUG | Administered subcutaneously. |
| Placebo | DRUG | Administered subcutaneously. |
| Moxifloxacin | DRUG | Participants will receive moxifloxacin orally. |
| Placebo for Maridebart Cafraglutide | DRUG | Participants will receive placebo for maridebart cafraglutide SC. |
| Placebo for Moxifloxacin | DRUG | Participants will receive placebo for moxifloxacin orally. |
Inclusion Criteria: * Signed informed consent form (ICF) indicating compliance with the requirements and restrictions listed in the ICF and this protocol. * Participants completing Study 20210184 must meet the following criteria: * Completed the Week 72 visit in Study 20210184. * Did not perma...
Maridebart Cafraglutide is an investigational drug being developed for Type 2 Diabetes Mellitus, overweight and obesity, and overweight or obesity with elevated liver fat. It is also being studied in adults with obesity or overweight who do not have Type 2 Diabetes Mellitus. The drug is currently in Phase 3 clinical development.
Maridebart Cafraglutide is a small molecule being developed by Amgen Inc. (AMGN) for cardiovascular conditions. It is being evaluated in clinical trials for its effects on weight and metabolic parameters in people with obesity and overweight, with or without Type 2 Diabetes Mellitus.
Maridebart Cafraglutide is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. Amgen is conducting clinical trials to evaluate the drug's safety and efficacy in treating obesity, overweight, and Type 2 Diabetes Mellitus.
Maridebart Cafraglutide is in Phase 3 clinical development. It is being studied in a large Phase 3 trial enrolling approximately 3,853 adults without Type 2 Diabetes Mellitus who have obesity or are overweight. The drug is investigational and not yet approved by regulatory authorities.
Maridebart Cafraglutide has been studied in several trials, including NCT04478708, a Phase 1 dose-escalation study in participants with obesity, and NCT05669599, a Phase 2 dose-ranging study in adults with overweight or obesity with or without Type 2 Diabetes Mellitus. A Phase 3 trial, NCT06858839, is currently active but not recruiting.
Yes, Maridebart Cafraglutide is also known as AMG 133. Clinical trials such as NCT04478708 and NCT05669599 refer to the drug as AMG 133, while later trials like NCT06858839 use the name Maridebart Cafraglutide. Both names refer to the same investigational compound.