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
- Conditions
- Type 2 Diabetes MellitusOverweightObesity
- Interventions
- Drug: Placebo
- Registration Number
- NCT05669599
- Lead Sponsor
- Amgen
- Brief Summary
The study aims to compare and assess the dose response of 3 selected doses of maridebart cafraglutide 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 592
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A: Maridebart Cafraglutide Placebo 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 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 Placebo 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 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 A: Maridebart Cafraglutide Maridebart Cafraglutide 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: Placebo Maridebart Cafraglutide 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 A: Placebo Maridebart Cafraglutide 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 Maridebart Cafraglutide 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.
- Primary Outcome Measures
Name Time Method Percent Change From Baseline to Week 52 in Body Weight Baseline and Week 52
- Secondary Outcome Measures
Name Time Method Change from Baseline to Week 52 in Diastolic Blood Pressure (DBP) Baseline and Week 52 Percent Change From Baseline to Week 52 in High-sensitivity C-reactive Protein (hs-CRP) Baseline and Week 52 Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Baseline and Week 52 Achievement of ≥ 20% Reduction in Body Weight From Baseline at Week 52 Baseline and Week 52 Change from Baseline to Week 52 in Hemoglobin A1c (HbA1c) Baseline and Week 52 Maximum Observed Plasma Concentration (Cmax) of maridebart cafraglutide Up to Week 64 Area Under the Concentration-time Curve (AUC) of maridebart cafraglutide Up to Week 64 Percent Change From Baseline in Total Cholesterol Baseline and Week 52 Percent Change From Baseline in non-HDL-C Baseline and Week 52 Percentage of Participants Achieving ≥ 10% Reduction in Body Weight From Baseline at Week 52 Baseline and Week 52 Achievement of ≥ 15% Reduction in Body Weight From Baseline at Week 52 Baseline and Week 52 Change from Baseline to Week 52 in Systolic Blood Pressure (SBP) Baseline and Week 52 Change from Baseline to Week 52 in Body Mass Index (BMI) Baseline and Week 52 Change from Baseline to Week 52 in Fasting Plasma Glucose Baseline and Week 52 Change from Baseline to Week 52 in Waist Circumference Baseline and Week 52 Percent Change From Baseline in Very-low-density Lipoprotein Cholesterol (VLDL-C) Baseline and Week 52 Percentage of Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 52 Baseline and Week 52 Change from Baseline to Week 52 in Fasting Serum Insulin Baseline and Week 52 Change from Baseline to Week 52 in Homeostasis Model Assessment for Insulin Resistance (HOMA2-IR) Baseline and Week 52 Change from Baseline to Week 52 in Homeostasis Model Assessment for Steady State Beta Cell Function (HOMA2-%B) Baseline and Week 52 Change from Baseline to Week 52 in Body Weight Baseline and Week 52 Change from Baseline to Week 52 in Body Fat Mass Using Dual-energy X-ray Absorptiometry (DEXA) Baseline and Week 52 Analyzed in a subset of participants.
Change from Baseline to Week 52 in Lean Body Mass Using DEXA Baseline and Week 52 Analyzed in a subset of participants.
Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) Baseline and Week 52 Percent Change From Baseline in Triglycerides Baseline and Week 52 Percent Change From Baseline in Free Fatty Acids (FFA) Baseline and Week 52
Trial Locations
- Locations (78)
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Diablo Clinical Research
🇺🇸Walnut Creek, California, United States
Research Innovations LLC dba Internal Medicine Care Inc
🇺🇸Beavercreek, Ohio, United States
Lucas Research
🇺🇸Morehead City, North Carolina, United States
Headlands Research Brownsville
🇺🇸Brownsville, Texas, United States
University of Calgary
🇨🇦Calgary, Alberta, Canada
Universitaetsmedizin Leipzig
🇩🇪Leipzig, Germany
Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
🇯🇵Matsuyama-shi, Ehime, Japan
Wellness Tenjin Clinic
🇯🇵Fukuoka-shi, Fukuoka, Japan
Mazda Hospital of Mazda Motor Corporation
🇯🇵Aki-gun, Hiroshima, Japan
Nihonbashi Sakura Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Dongguk University Ilsan Hospital
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Centrum Badan Klinicznych PI-House Spzoo
🇵🇱Gdansk, Poland
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Clinical Medical and Analytical eXellence CMAX
🇦🇺Adelaide, South Australia, Australia
University of Chicago
🇺🇸Chicago, Illinois, United States
Great Lakes Clinical Trials
🇺🇸Chicago, Illinois, United States
Alliance for Multispecialty Research Norman
🇺🇸Norman, Oklahoma, United States
Centricity Research Brampton Endocrinology
🇨🇦Brampton, Ontario, Canada
Pinnacle Clinical Research
🇺🇸San Antonio, Texas, United States
Clinical Trials of Texas
🇺🇸San Antonio, Texas, United States
Diabetes and Glandular Disease Clinic
🇺🇸San Antonio, Texas, United States
Texas Diabetes Institute
🇺🇸San Antonio, Texas, United States
East-West Medical Research
🇺🇸Honolulu, Hawaii, United States
Alliance for Multispecialty Research Mobile
🇺🇸Mobile, Alabama, United States
Foothills Research Center
🇺🇸Phoenix, Arizona, United States
Ark Clinical Research- Tustin
🇺🇸Tustin, California, United States
HonorHealth
🇺🇸Scottsdale, Arizona, United States
Ark Clinical Research- Long Beach
🇺🇸Long Beach, California, United States
Alliance for Multispecialty Research Miami
🇺🇸Coral Gables, Florida, United States
Alliance for Multispecialty Research Newton
🇺🇸Newton, Kansas, United States
StudyMetrix Research
🇺🇸Saint Peters, Missouri, United States
State University of New York Upstate Medical University
🇺🇸Syracuse, New York, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
PanAmerican Clinical Research LLC
🇺🇸Brownsville, Texas, United States
Royal Prince Alfred Hospital (RPAH) Clinic
🇦🇺Camperdown, New South Wales, Australia
St Vincents Hospital Melbourne
🇦🇺Fitzroy, Victoria, Australia
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Baker Heart and Diabetes Institute
🇦🇺Melbourne, Victoria, Australia
Clinique des Maladies Lipidiques de Quebec Incorporated
🇨🇦Quebec, Canada
Institut Universitaire de cardiologie et de pneumologie de Quebec
🇨🇦Quebec, Canada
Centricity Research Vaughan Endocrinology
🇨🇦Concord, Ontario, Canada
Endokrinologicky ustav
🇨🇿Praha 1, Czechia
Institut klinicke a experimentalni mediciny
🇨🇿Praha 4, Czechia
Vseobecna fakultni nemocnice v Praze
🇨🇿Praha 2, Czechia
Charite - Universitaetsmedizin Berlin, Campus Mitte
🇩🇪Berlin, Germany
Diabeteszentrum Hamburg West
🇩🇪Hamburg, Germany
Budapesti Szent Ferenc Korhaz
🇭🇺Budapest, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
🇭🇺Pecs, Hungary
Matsunami Health Promotion Clinic
🇯🇵Hashima-gun, Gifu, Japan
Nishiyamado Keiwa Hospital
🇯🇵Naka-shi, Ibaraki, Japan
MIH Clinic Yoyogi
🇯🇵Shibuya-ku, Tokyo, Japan
Shiraiwa Medical Clinic
🇯🇵Kashiwara-shi, Osaka, Japan
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
AthleticoMed
🇵🇱Bydgoszcz, Poland
Centrum Terapii Wspolczesnej
🇵🇱Lodz, Poland
AppleTreeClinics Network Spzoo
🇵🇱Lodz, Poland
Clinical Best Solutions Sp zoo Spolka Komandytowa
🇵🇱Lublin, Poland
Hospital Clinico Universitario Virgen de la Victoria
🇪🇸Malaga, Andalucía, Spain
Hospital Vithas Sevilla
🇪🇸Castilleja de la Cuesta, Andalucía, Spain
Migre Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
🇵🇱Wroclaw, Poland
Hospital Universitario Arnau de Vilanova Lleida
🇪🇸Lleida, Cataluña, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Complexo Hospitalario Universitario A Coruña
🇪🇸A Coruña, Galicia, Spain
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Orange County Research Center
🇺🇸Tustin, California, United States
Austin Health, Heidelberg Repatriation Hospital
🇦🇺Heidelberg Heights, Victoria, Australia
Prince of Wales Hospital
🇭🇰Shatin, New Territories, Hong Kong
CRU Hungary Kft
🇭🇺Encs, Hungary
Medical Care LLC
🇺🇸Elizabethton, Tennessee, United States
Nakakinen Clinic
🇯🇵Naka-shi, Ibaraki, Japan
China Medical University Hospital
🇨🇳Taichung, Taiwan
Clinexpert Kft
🇭🇺Budapest, Hungary
Louisville Metabolic and Atherosclerosis Research Center
🇺🇸Louisville, Kentucky, United States
Alliance for Multispecialty Research Kansas City
🇺🇸Kansas City, Missouri, United States
Tandem Clinical Research - Marrero
🇺🇸Marrero, Louisiana, United States