Clinical trials: sponsored by Amgen
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Various Degrees of Hepatic Impairment
The primary objective of the study is to evaluate the pharmacokinetics (PK) of a single dose of olpasiran in participants with mild, moderate, or severe hepatic impairment compared to participants with normal hepatic function.
- Trial name
- NCT05481411
- Testing
- Olpasiran
- Where
- 3 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Amgen
Migraine
Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine
This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to <12 years) and adolescents (12 to <18 years) with chronic migraine.
- Trial name
- OASIS(CM) (NCT03832998)
- Testing
- Erenumab Dose 1, Erenumab Dose 2, Erenumab Dose 3
- Where
- 101 sites in United States, Belgium and 11 more
- Volunteers
- 284 people
- Sponsor
- Amgen
Healthy Participants
A Phase 1 Trial of AMG 691 in Healthy Chinese and Japanese Volunteers
The trial is designed to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of AMG 691 in healthy Chinese and Japanese participants
- Trial name
- NCT07745907
- Testing
- AMG 691
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Amgen
Atherosclerotic Cardiovascular Disease
Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial
The primary objective of this trial is to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in…
- Trial name
- NCT05581303
- Testing
- Olpasiran
- Where
- 492 sites in United States, Australia and 22 more
- Volunteers
- 7,297 people
- Sponsor
- Amgen
Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants…
- Trial name
- FORTITUDE-101 (NCT05052801)
- Testing
- Bemarituzumab, mFOLFOX6
- Where
- 300 sites in United States, Argentina and 35 more
- Volunteers
- 547 people
- Sponsor
- Amgen
Advanced Solid Tumors
Study of AMG 256 in Adult Subjects With Advanced Solid Tumors
To evaluate the safety and tolerability of AMG 256 in adult participants and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
- Trial name
- NCT04362748
- Testing
- AMG 256
- Where
- 11 sites in United States, Australia and 2 more
- Volunteers
- 34 people
- Sponsor
- Amgen
Generalized Myasthenia Gravis
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Generalized Myasthenia Gravis (gMG)
The primary objectives of this study are to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of inebilizumab administered in pediatric participants with gMG, and to assess the safety and tolerability of…
- Trial name
- THYME (NCT06987539)
- Testing
- Inebilizumab
- Where
- 14 sites in United States, Argentina and 6 more
- Volunteers
- 15 people
- Sponsor
- Amgen
Plaque Psoriasis
A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis
The primary objective of this post-marketing study is to assess the safety and tolerability of apremilast in pediatric participants (ages 6 through 17 years) with mild to moderate plaque psoriasis.
- Trial name
- NCT06088199
- Testing
- Apremilast
- Where
- 30 sites in United States
- Volunteers
- 51 people
- Sponsor
- Amgen
Obesity or Overweight
Efficacy, Safety and Tolerability of Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA) to Maridebart Cafraglutide in Adults With Obesity or Overweight (MARITIME-SWITCH)
Efficacy, safety and tolerability of switching from GLP-1RA to maridebart cafraglutide in adults with obesity or overweight.
- Trial name
- NCT07575399
- Testing
- Maridebart Cafraglutide
- Where
- 54 sites in United States, Puerto Rico
- Volunteers
- 300 people
- Sponsor
- Amgen
Atopic Dermatitis
A Study to Assess Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy Participants
The primary objective of the study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) dose in a vial compared to a prefilled syringe in healthy participants.
- Trial name
- NCT06268860
- Testing
- Rocatinlimab vial injection, Rocatinlimab prefilled syringe
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Amgen
Chemotherapy-induced Thrombocytopenia
Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Gastrointestinal, Pancreatic, or Colorectal Cancer
Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects with Gastrointestinal, Pancreatic, or Colorectal Cancer
- Trial name
- RECITE (NCT03362177)
- Testing
- Romiplostim
- Where
- 117 sites in United States, Argentina and 18 more
- Volunteers
- 165 people
- Sponsor
- Amgen
Renal Impairment
A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Normal Renal Function and Participants With Various Degrees of Renal Impairment
The primary objective of this study is to evaluate the pharmacokinetics (PK) of a single dose of olpasiran in participants with normal renal function and participants with various degrees of renal impairment.
- Trial name
- NCT05489614
- Testing
- Olpasiran
- Where
- 6 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Amgen
Basic Science
A Study to Assess the Effect of Olpasiran on QT/QTc Intervals in Healthy Participants
The primary objective of the study is: To assess the effects of a single therapeutic and supratherapeutic dose of olpasiran on the placebo-corrected change from baseline in QT corrected for heart rate (ΔΔQT)/QTc interval in…
- Trial name
- NCT06411860
- Testing
- Olpasiran, Moxifloxacin
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Amgen
Non-Small Cell Lung Cancer (NSCLC)
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum…
- Trial name
- NCT05920356
- Testing
- Sotorasib, Pembrolizumab
- Where
- 424 sites in United States, Argentina and 36 more
- Volunteers
- 750 people
- Sponsor
- Amgen
Postmenopausal Osteoporosis
A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture.
The primary objective of this study is to characterize safety and tolerability of romosozumab in postmenopausal women with osteoporosis and a high risk of fracture in India.
- Trial name
- NCT06079476
- Testing
- Romosozumab
- Where
- 10 sites in India
- Volunteers
- 100 people
- Sponsor
- Amgen
Extensive Stage Small Cell Lung Cancer
Study Evaluating Tarlatamab in Chinese Participants With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment
The primary aim of this study is to evaluate the efficacy of tarlatamab as assessed by objective response rate (ORR) based on blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors version 1.1…
- Trial name
- DeLLphi-307 (NCT06502977)
- Testing
- Tarlatamab
- Where
- 12 sites in China
- Volunteers
- 32 people
- Sponsor
- Amgen
Metastatic or Locally Advanced Solid Tumors With Microsatellite Instability-high (MSI-H) or Mismatched Repair Deficiency (dMMR)
AMG 436 as Monotherapy and Combination Therapy in Participants With MSI-H/dMMR Solid Tumors
The primary objectives of this trial are to evaluate the safety profile of AMG 436 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for AMG 436 as monotherapy and in combination with other anti-cancer…
- Trial name
- NCT07403721
- Testing
- AMG 436
- Where
- 27 sites in United States, Australia and 8 more
- Volunteers
- 464 people
- Sponsor
- Amgen
Metastatic Castration-resistant Prostate Cancer
A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
The primary objective of this study is to compare overall survival (OS) in participants receiving xaluritamig plus abiraterone against investigator's choice (docetaxel, cabazitaxel, or abiraterone).
- Trial name
- NCT07213674
- Testing
- Xaluritamig, Abiraterone acetate, Docetaxel
- Where
- 159 sites in United States, Australia and 16 more
- Volunteers
- 750 people
- Sponsor
- Amgen
Active Juvenile Psoriatic Arthritis
Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis
The study will aim to estimate the efficacy of apremilast compared with placebo in the treatment of juvenile psoriatic arthritis (JPsA) in pediatric participants 5 to less than 18 years of age.
- Trial name
- PEAPOD (NCT04804553)
- Testing
- Apremilast
- Where
- 44 sites in Belgium, France and 12 more
- Volunteers
- 60 people
- Sponsor
- Amgen
Advanced Solid Tumors
Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors
The primary objective of this study is to: Evaluate the safety and tolerability of AMG 305 in adult participants Determine the optimal biologically active dose (OBD), at or below the maximum tolerated dose (MTD) with MTD 1 as the…
- Trial name
- NCT05800964
- Testing
- AMG 305
- Where
- 27 sites in United States, Australia and 7 more
- Volunteers
- 37 people
- Sponsor
- Amgen
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