Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main objective of this trial is to evaluate the pharmacokinetics (PK) of maridebart cafraglutide administered as a single dose using two different SC presentations in participants living with overweight or obesity.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maridebart Cafraglutide | Drug | Maridebart cafraglutide will be administered SC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf) of Maridebart Cafraglutide | Up to Day 120 | |
| Area Under the Plasma Concentration Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Maridebart Cafraglutide | Up to Day 120 | |
| Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide | Up to Day 120 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-emergent Adverse Events | Up to Day 120 | |
| Number of Participants with Serious Adverse Events | Up to Day 120 | |
| Number of Participants with Anti-maridebart Cafraglutide Antibody Formation |
Not provided
Inclusion Criteria
Male or female, of any race, between 18 and 60 years of age, inclusive.
a. Females must not be pregnant or lactating.
Body mass index between ≥25.0 and <40.0 kg/m^2.
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials | Anaheim | California | 92801-2658 | United States | ||
| Fortrea Clinical Research Unit - Daytona Beach |
Not provided
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Up to Day 120 |
| Daytona Beach |
| Florida |
| 32117-5116 |
| United States |
| Fortrea Clinical Research Unit - Dallas | Dallas | Texas | 75247-4989 | United States |
| Fortrea Clinical Research Unit Inc. - Madison | Madison | Wisconsin | 53704-2526 | United States |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided