Back to resultsDose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Participants With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus
Primary Purpose
Obesity, Overweight, Type 2 Diabetes Mellitus
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AMG 133
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
Inclusion Criteria: Age ≥18 years at the time of signing informed consent. BMI ≥30 kg/m^2, or ≥27 kg/m^2 and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease. For participants in cohort B only, HbA1c ≥ 7% and ≤ 10% (53 to 86 mmol/mol) at screening with an established diagnosis of type 2 diabetes mellitus for ≥ 180 days prior to screening and either treated with diet and exercise alone or on stable (at least 90 days prior to screening) treatment with metformin, a sulfonylurea, or a sodium-glucose cotransporter 2 (SGLT2) inhibitor as monotherapy or combination therapy, per approved local label. History of at least one unsuccessful dietary effort to lose body weight. Exclusion Criteria: Change in body weight greater than 5 kg within 3 months prior to screening. Obesity induced by other endocrinologic disorders. History of pancreatitis. Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2). History of major depressive disorder within the last 2 years. Any lifetime history of other major psychiatric disorder or suicide attempt.
Sites / Locations
- Alliance for Multispecialty Research MobileRecruiting
- Foothills Research CenterRecruiting
- HonorHealthRecruiting
- Ark Clinical Research- Long BeachRecruiting
- Ark Clinical Research- TustinRecruiting
- Orange County Research CenterRecruiting
- Diablo Clinical ResearchRecruiting
- Alliance for Multispecialty Research MiamiRecruiting
- Progressive Medical ResearchRecruiting
- East-West Medical ResearchRecruiting
- University of ChicagoRecruiting
- Great Lakes Clinical TrialsRecruiting
- Alliance for Multispecialty Research NewtonRecruiting
- Louisville Metabolic and Atherosclerosis Research CenterRecruiting
- Tandem Clinical Research - MarreroRecruiting
- Alliance for Multispecialty Research Kansas CityRecruiting
- StudyMetrix ResearchRecruiting
- State University of New York Upstate Medical UniversityRecruiting
- Lucas ResearchRecruiting
- Research Innovations LLC dba Internal Medicine Care IncRecruiting
- The Christ HospitalRecruiting
- Alliance for Multispecialty Research NormanRecruiting
- Medical Care LLCRecruiting
- PanAmerican Clinical Research LLCRecruiting
- Headlands Research BrownsvilleRecruiting
- Clinical Trials of TexasRecruiting
- Diabetes and Glandular Disease ClinicRecruiting
- Pinnacle Clinical ResearchRecruiting
- Texas Diabetes InstituteRecruiting
- Royal Prince Alfred Hospital (RPAH) ClinicRecruiting
- Clinical Medical and Analytical eXellence CMAXRecruiting
- Monash Medical CentreRecruiting
- St Vincents Hospital MelbourneRecruiting
- Austin Health, Heidelberg Repatriation HospitalRecruiting
- Baker Heart and Diabetes InstituteRecruiting
- University of CalgaryRecruiting
- Centricity Research Brampton EndocrinologyRecruiting
- Centricity Research Vaughan EndocrinologyRecruiting
- Institut Universitaire de cardiologie et de pneumologie de QuebecRecruiting
- Clinique des Maladies Lipidiques de Quebec IncorporatedRecruiting
- Endokrinologicky ustavRecruiting
- Vseobecna fakultni nemocnice v PrazeRecruiting
- Institut klinicke a experimentalni medicinyRecruiting
- Charite - Universitaetsmedizin Berlin, Campus MitteRecruiting
- Diabeteszentrum Hamburg WestRecruiting
- Universitaetsmedizin LeipzigRecruiting
- Prince of Wales HospitalRecruiting
- Budapesti Szent Ferenc KorhazRecruiting
- Clinexpert KftRecruiting
- CRU Hungary KftRecruiting
- Pecsi Tudomanyegyetem Klinikai KozpontRecruiting
- Mikannohana Clinic, Diabetes, Endocrinology and MetabolismRecruiting
- Wellness Tenjin ClinicRecruiting
- Matsunami Health Promotion ClinicRecruiting
- Mazda Hospital of Mazda Motor CorporationRecruiting
- Nakakinen ClinicRecruiting
- Nishiyamado Keiwa HospitalRecruiting
- Shiraiwa Medical ClinicRecruiting
- Nihonbashi Sakura ClinicRecruiting
- MIH Clinic YoyogiRecruiting
- Dongguk University Ilsan HospitalRecruiting
- Gachon University Gil Medical CenterRecruiting
- Seoul National University Bundang HospitalRecruiting
- Kangbuk Samsung HospitalRecruiting
- AthleticoMedRecruiting
- Centrum Badan Klinicznych PI-House SpzooRecruiting
- Centrum Terapii WspolczesnejRecruiting
- AppleTreeClinics Network SpzooRecruiting
- Clinical Best Solutions Sp zoo Spolka KomandytowaRecruiting
- Migre Polskie Centrum Leczenia Migreny Anna Gryglas-DworakRecruiting
- Hospital Vithas SevillaRecruiting
- Hospital Clinico Universitario Virgen de la VictoriaRecruiting
- Hospital Universitario Arnau de Vilanova LleidaRecruiting
- Complexo Hospitalario Universitario A CoruñaRecruiting
- Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
- China Medical University HospitalRecruiting
- National Cheng Kung University HospitalRecruiting
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Cohort A: AMG 133
Cohort A: Placebo
Cohort B: AMG 133
Cohort B: Placebo
Arm Description
Cohort A will consist of participants without a diagnosis of type 1 or type 2 diabetes mellitus. Participants will be randomized to receive AMG 133 or placebo in 1 of 7 dose cohorts.
Cohort A will consist of participants without a diagnosis of type 1 or type 2 diabetes mellitus. Participants will be randomized to receive AMG 133 or placebo in 1 of 7 dose cohorts.
Cohort B will consist of participants with a diagnosis of type 2 diabetes mellitus. Participants will be randomized to receive AMG 133 or placebo in 1 of 4 dose cohorts.
Cohort B will consist of participants with a diagnosis of type 2 diabetes mellitus. Participants will be randomized to receive AMG 133 or placebo in 1 of 4 dose cohorts.
Outcomes
Primary Outcome Measures
Percent Change From Baseline to Week 52 in Body Weight
Secondary Outcome Measures
Percentage of Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 52
Percentage of Participants Achieving ≥ 10% Reduction in Body Weight From Baseline at Week 52
Percentage of Participants Achieving ≥ 15% Reduction in Body Weight From Baseline at Week 52
Percentage of Participants Achieving ≥ 20% Reduction in Body Weight From Baseline at Week 52
Change from Baseline to Week 52 in Hemoglobin A1c (HbA1c)
Change from Baseline to Week 52 in Fasting Serum Insulin
Change from Baseline to Week 52 in Fasting Plasma Glucose
Change from Baseline to Week 52 in Homeostasis Model Assessment for Insulin Resistance (HOMA2-IR)
Change from Baseline to Week 52 in Homeostasis Model Assessment for Steady State Beta Cell Function (HOMA2-%B)
Maximum Observed Plasma Concentration (Cmax) of AMG 133
Area Under the Concentration-time Curve (AUC) of AMG 133
Change from Baseline to Week 52 in Waist Circumference
Change from Baseline to Week 52 in Body Weight
Change from Baseline to Week 52 in Systolic Blood Pressure (SBP)
Change from Baseline to Week 52 in Diastolic Blood Pressure (DBP)
Change from Baseline to Week 52 in Body Fat Using Dual-energy X-ray Absorptiometry (DEXA)
Analyzed in a subset of participants.
Change from Baseline to Week 52 in Lean Body Mass Using DEXA
Analyzed in a subset of participants.
Percent Change From Baseline to Week 52 in High-sensitivity C-reactive Protein (hs-CRP)
Change from Baseline to Week 52 in Body Mass Index (BMI)
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Percent Change From Baseline in Total Cholesterol
Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
Percent Change From Baseline in non-HDL-C
Percent Change From Baseline in Very-low-density Lipoprotein Cholesterol (VLDL-C)
Percent Change From Baseline in Triglycerides
Percent Change From Baseline in Free Fatty Acids (FFA)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05669599
Brief Title
Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Participants With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus
Official Title
A Phase 2 Randomized, Placebo-controlled, Double-blind, Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2023 (Actual)
Primary Completion Date
October 6, 2024 (Anticipated)
Study Completion Date
December 28, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study aims to compare and assess the dose response of 3 selected doses of AMG 133 compared with placebo, on inducing and maintaining weight loss from baseline at Week 52 in participants with overweight or obesity without diabetes mellitus (Cohort A) and in participants with overweight or obesity with Type 2 diabetes mellitus (Cohort B).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
570 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort A: AMG 133
Arm Type
Experimental
Arm Description
Cohort A will consist of participants without a diagnosis of type 1 or type 2 diabetes mellitus. Participants will be randomized to receive AMG 133 or placebo in 1 of 7 dose cohorts.
Arm Title
Cohort A: Placebo
Arm Type
Placebo Comparator
Arm Description
Cohort A will consist of participants without a diagnosis of type 1 or type 2 diabetes mellitus. Participants will be randomized to receive AMG 133 or placebo in 1 of 7 dose cohorts.
Arm Title
Cohort B: AMG 133
Arm Type
Experimental
Arm Description
Cohort B will consist of participants with a diagnosis of type 2 diabetes mellitus. Participants will be randomized to receive AMG 133 or placebo in 1 of 4 dose cohorts.
Arm Title
Cohort B: Placebo
Arm Type
Placebo Comparator
Arm Description
Cohort B will consist of participants with a diagnosis of type 2 diabetes mellitus. Participants will be randomized to receive AMG 133 or placebo in 1 of 4 dose cohorts.
Intervention Type
Biological
Intervention Name(s)
AMG 133
Intervention Description
Participants will receive AMG 133 through 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive placebo through 48 weeks.
Primary Outcome Measure Information:
Title
Percent Change From Baseline to Week 52 in Body Weight
Time Frame
Baseline and Week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 52
Time Frame
Baseline and Week 52
Title
Percentage of Participants Achieving ≥ 10% Reduction in Body Weight From Baseline at Week 52
Time Frame
Baseline and Week 52
Title
Percentage of Participants Achieving ≥ 15% Reduction in Body Weight From Baseline at Week 52
Time Frame
Baseline and Week 52
Title
Percentage of Participants Achieving ≥ 20% Reduction in Body Weight From Baseline at Week 52
Time Frame
Baseline and Week 52
Title
Change from Baseline to Week 52 in Hemoglobin A1c (HbA1c)
Time Frame
Baseline and Week 52
Title
Change from Baseline to Week 52 in Fasting Serum Insulin
Time Frame
Baseline and Week 52
Title
Change from Baseline to Week 52 in Fasting Plasma Glucose
Time Frame
Baseline and Week 52
Title
Change from Baseline to Week 52 in Homeostasis Model Assessment for Insulin Resistance (HOMA2-IR)
Time Frame
Baseline and Week 52
Title
Change from Baseline to Week 52 in Homeostasis Model Assessment for Steady State Beta Cell Function (HOMA2-%B)
Time Frame
Baseline and Week 52
Title
Maximum Observed Plasma Concentration (Cmax) of AMG 133
Time Frame
Up to Week 64
Title
Area Under the Concentration-time Curve (AUC) of AMG 133
Time Frame
Up to Week 64
Title
Change from Baseline to Week 52 in Waist Circumference
Time Frame
Baseline and Week 52
Title
Change from Baseline to Week 52 in Body Weight
Time Frame
Baseline and Week 52
Title
Change from Baseline to Week 52 in Systolic Blood Pressure (SBP)
Time Frame
Baseline and Week 52
Title
Change from Baseline to Week 52 in Diastolic Blood Pressure (DBP)
Time Frame
Baseline and Week 52
Title
Change from Baseline to Week 52 in Body Fat Using Dual-energy X-ray Absorptiometry (DEXA)
Description
Analyzed in a subset of participants.
Time Frame
Baseline and Week 52
Title
Change from Baseline to Week 52 in Lean Body Mass Using DEXA
Description
Analyzed in a subset of participants.
Time Frame
Baseline and Week 52
Title
Percent Change From Baseline to Week 52 in High-sensitivity C-reactive Protein (hs-CRP)
Time Frame
Baseline and Week 52
Title
Change from Baseline to Week 52 in Body Mass Index (BMI)
Time Frame
Baseline and Week 52
Title
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Time Frame
Baseline and Week 52
Title
Percent Change From Baseline in Total Cholesterol
Time Frame
Baseline and Week 52
Title
Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
Time Frame
Baseline and Week 52
Title
Percent Change From Baseline in non-HDL-C
Time Frame
Baseline and Week 52
Title
Percent Change From Baseline in Very-low-density Lipoprotein Cholesterol (VLDL-C)
Time Frame
Baseline and Week 52
Title
Percent Change From Baseline in Triglycerides
Time Frame
Baseline and Week 52
Title
Percent Change From Baseline in Free Fatty Acids (FFA)
Time Frame
Baseline and Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years at the time of signing informed consent.
BMI ≥30 kg/m^2, or ≥27 kg/m^2 and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease.
For participants in cohort B only, HbA1c ≥ 7% and ≤ 10% (53 to 86 mmol/mol) at screening with an established diagnosis of type 2 diabetes mellitus for ≥ 180 days prior to screening and either treated with diet and exercise alone or on stable (at least 90 days prior to screening) treatment with metformin, a sulfonylurea, or a sodium-glucose cotransporter 2 (SGLT2) inhibitor as monotherapy or combination therapy, per approved local label.
History of at least one unsuccessful dietary effort to lose body weight.
Exclusion Criteria:
Change in body weight greater than 5 kg within 3 months prior to screening.
Obesity induced by other endocrinologic disorders.
History of pancreatitis.
Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2).
History of major depressive disorder within the last 2 years.
Any lifetime history of other major psychiatric disorder or suicide attempt.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amgen Call Center
Phone
866-572-6436
Email
medinfo@amgen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Alliance for Multispecialty Research Mobile
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Individual Site Status
Recruiting
Facility Name
Foothills Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85044
Country
United States
Individual Site Status
Recruiting
Facility Name
HonorHealth
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Recruiting
Facility Name
Ark Clinical Research- Long Beach
City
Long Beach
State/Province
California
ZIP/Postal Code
90815
Country
United States
Individual Site Status
Recruiting
Facility Name
Ark Clinical Research- Tustin
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Individual Site Status
Recruiting
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Individual Site Status
Recruiting
Facility Name
Diablo Clinical Research
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance for Multispecialty Research Miami
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Individual Site Status
Recruiting
Facility Name
East-West Medical Research
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Name
Great Lakes Clinical Trials
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance for Multispecialty Research Newton
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Individual Site Status
Recruiting
Facility Name
Louisville Metabolic and Atherosclerosis Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Individual Site Status
Recruiting
Facility Name
Tandem Clinical Research - Marrero
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance for Multispecialty Research Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Individual Site Status
Recruiting
Facility Name
StudyMetrix Research
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Individual Site Status
Recruiting
Facility Name
State University of New York Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Recruiting
Facility Name
Lucas Research
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Innovations LLC dba Internal Medicine Care Inc
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45431
Country
United States
Individual Site Status
Recruiting
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance for Multispecialty Research Norman
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Care LLC
City
Elizabethton
State/Province
Tennessee
ZIP/Postal Code
37643
Country
United States
Individual Site Status
Recruiting
Facility Name
PanAmerican Clinical Research LLC
City
Brownsville
State/Province
Texas
ZIP/Postal Code
78520
Country
United States
Individual Site Status
Recruiting
Facility Name
Headlands Research Brownsville
City
Brownsville
State/Province
Texas
ZIP/Postal Code
78526
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trials of Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Diabetes and Glandular Disease Clinic
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Pinnacle Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Diabetes Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Individual Site Status
Recruiting
Facility Name
Royal Prince Alfred Hospital (RPAH) Clinic
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2006
Country
Australia
Individual Site Status
Recruiting
Facility Name
Clinical Medical and Analytical eXellence CMAX
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3146
Country
Australia
Individual Site Status
Recruiting
Facility Name
St Vincents Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Recruiting
Facility Name
Austin Health, Heidelberg Repatriation Hospital
City
Heidelberg Heights
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Individual Site Status
Recruiting
Facility Name
Baker Heart and Diabetes Institute
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2T 5C7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centricity Research Brampton Endocrinology
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6S 0C6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centricity Research Vaughan Endocrinology
City
Concord
State/Province
Ontario
ZIP/Postal Code
L4K 4M2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Institut Universitaire de cardiologie et de pneumologie de Quebec
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Clinique des Maladies Lipidiques de Quebec Incorporated
City
Quebec
ZIP/Postal Code
G1V 4W2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Endokrinologicky ustav
City
Praha 1
ZIP/Postal Code
116 94
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Institut klinicke a experimentalni mediciny
City
Praha 4
ZIP/Postal Code
140 21
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Charite - Universitaetsmedizin Berlin, Campus Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Name
Diabeteszentrum Hamburg West
City
Hamburg
ZIP/Postal Code
22607
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsmedizin Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Prince of Wales Hospital
City
Shatin, New Territories
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Budapesti Szent Ferenc Korhaz
City
Budapest
ZIP/Postal Code
1021
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Clinexpert Kft
City
Budapest
ZIP/Postal Code
1033
Country
Hungary
Individual Site Status
Recruiting
Facility Name
CRU Hungary Kft
City
Encs
ZIP/Postal Code
3860
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Pecsi Tudomanyegyetem Klinikai Kozpont
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
City
Matsuyama-shi
State/Province
Ehime
ZIP/Postal Code
790-0034
Country
Japan
Individual Site Status
Recruiting
Facility Name
Wellness Tenjin Clinic
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
810-0001
Country
Japan
Individual Site Status
Recruiting
Facility Name
Matsunami Health Promotion Clinic
City
Hashima-gun
State/Province
Gifu
ZIP/Postal Code
501-6061
Country
Japan
Individual Site Status
Recruiting
Facility Name
Mazda Hospital of Mazda Motor Corporation
City
Aki-gun
State/Province
Hiroshima
ZIP/Postal Code
735-8585
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nakakinen Clinic
City
Naka-shi
State/Province
Ibaraki
ZIP/Postal Code
311-0113
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nishiyamado Keiwa Hospital
City
Naka-shi
State/Province
Ibaraki
ZIP/Postal Code
311-0133
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shiraiwa Medical Clinic
City
Kashiwara-shi
State/Province
Osaka
ZIP/Postal Code
582-0005
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nihonbashi Sakura Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0025
Country
Japan
Individual Site Status
Recruiting
Facility Name
MIH Clinic Yoyogi
City
Shibuya-ku
State/Province
Tokyo
ZIP/Postal Code
151-0051
Country
Japan
Individual Site Status
Recruiting
Facility Name
Dongguk University Ilsan Hospital
City
Goyang-si, Gyeonggi-do
ZIP/Postal Code
10326
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si, Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
AthleticoMed
City
Bydgoszcz
ZIP/Postal Code
85-752
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Badan Klinicznych PI-House Spzoo
City
Gdansk
ZIP/Postal Code
80-546
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Terapii Wspolczesnej
City
Lodz
ZIP/Postal Code
90-338
Country
Poland
Individual Site Status
Recruiting
Facility Name
AppleTreeClinics Network Spzoo
City
Lodz
ZIP/Postal Code
90-349
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Best Solutions Sp zoo Spolka Komandytowa
City
Lublin
ZIP/Postal Code
20-078
Country
Poland
Individual Site Status
Recruiting
Facility Name
Migre Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
City
Wroclaw
ZIP/Postal Code
52-210
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hospital Vithas Sevilla
City
Castilleja de la Cuesta
State/Province
Andalucía
ZIP/Postal Code
41950
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario Virgen de la Victoria
City
Malaga
State/Province
Andalucía
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Arnau de Vilanova Lleida
City
Lleida
State/Province
Cataluña
ZIP/Postal Code
25198
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complexo Hospitalario Universitario A Coruña
City
A Coruña
State/Province
Galicia
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD Sharing Time Frame
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 (or other new use) 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.
IPD Sharing Access Criteria
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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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.
IPD Sharing URL
http://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Participants With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus
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