Clinical trial NCT05669599: 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
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Obesity
Overweight
Type 2 Diabetes Mellitus
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2023-01-03
Enrollment: 592
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

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