Clinical trial · ClinicalTrials.gov
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 133 in Adult Subjects With Overweight/Obesity
NCT03548935
Trial identity
- Registry
- ClinicalTrials.gov
- Registry ID
- NCT03548935
- Phase
- Phase 1
- Design
- Interventional
- Allocation
- Randomized
- Masking
- Double-blind
- Overall status
- Completed
- Result status
- published
Sponsors & collaborators
- Sponsor
- Amgen
- Collaborators
- —
Intervention assets
Arms
| Arm | Intervention | Enrollment |
|---|---|---|
| AMG 133 low dose | AMG 133 subcutaneous | — |
| AMG 133 high dose | AMG 133 subcutaneous | — |
| Placebo | placebo subcutaneous | — |
Population & enrollment
- Population summary
- Adults with overweight or obesity, with or without type 2 diabetes.
- Eligibility summary
- BMI 27-45 kg/m²; generally healthy or stable T2D on metformin.
- Planned enrollment
- 100
- Actual enrollment
- 100
Endpoints
- Primary endpoints
Safety and tolerability
Pharmacokinetics
- Secondary endpoints
Body weight change
Anti-drug antibodies
Dates
- Start date
- Mar 1, 2018
- Primary completion
- Dec 1, 2022
- Completion date
- Mar 1, 2023
- Last synced
- Aug 15, 2024
Locations
- United States
Plain-language interpretation
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 133 in Adult Subjects With Overweight/Obesity is a Phase 1 Interventional sponsored by Amgen. It is evaluating Maritide in Adults with overweight or obesity, with or without type 2 diabetes.. The primary endpoints are Safety and tolerability; Pharmacokinetics.
Registry disclaimer: Information is derived from public registry records and may lag behind the official source. Always verify against ClinicalTrials.gov.
Sources
- registryprimary record
A study to evaluate safety, tolerability, PK/PD of AMG 133 in adults with obesity
Amgen Inc. · ClinicalTrials.gov · Apr 4, 2018 · NCT03548935