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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05669599
• Other study ID #: 20190218
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 18, 2023
• Est. completion date: January 2, 2026

Study information

• Verified date: January 2024
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 592
• Est. completion date: January 2, 2026
• Est. primary completion date: October 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Overweight
• Type 2 Diabetes Mellitus

Intervention

Biological:
• AMG 133
Participants will receive AMG 133 by subcutaneous (SC) injection.

Drug:
• Placebo
Participants will receive placebo by SC injection.

Locations

Country	Name	City	State
Australia	Clinical Medical and Analytical eXellence CMAX	Adelaide	South Australia
Australia	Royal Prince Alfred Hospital (RPAH) Clinic	Camperdown	New South Wales
Australia	Monash Medical Centre	Clayton	Victoria
Australia	St Vincents Hospital Melbourne	Fitzroy	Victoria
Australia	Austin Health, Heidelberg Repatriation Hospital	Heidelberg Heights	Victoria
Australia	Baker Heart and Diabetes Institute	Melbourne	Victoria
Canada	Centricity Research Brampton Endocrinology	Brampton	Ontario
Canada	University of Calgary	Calgary	Alberta
Canada	Centricity Research Vaughan Endocrinology	Concord	Ontario
Canada	Clinique des Maladies Lipidiques de Quebec Incorporated	Quebec
Canada	Institut Universitaire de cardiologie et de pneumologie de Quebec	Quebec
Czechia	Endokrinologicky ustav	Praha 1
Czechia	Vseobecna fakultni nemocnice v Praze	Praha 2
Czechia	Institut klinicke a experimentalni mediciny	Praha 4
Germany	Charite - Universitaetsmedizin Berlin, Campus Mitte	Berlin
Germany	Diabeteszentrum Hamburg West	Hamburg
Germany	Universitaetsmedizin Leipzig	Leipzig
Hong Kong	Prince of Wales Hospital	Shatin, New Territories
Hungary	Budapesti Szent Ferenc Korhaz	Budapest
Hungary	Clinexpert Kft	Budapest
Hungary	CRU Hungary Kft	Encs
Hungary	Pecsi Tudomanyegyetem Klinikai Kozpont	Pecs
Japan	Mazda Hospital of Mazda Motor Corporation	Aki-gun	Hiroshima
Japan	Nihonbashi Sakura Clinic	Chuo-ku	Tokyo
Japan	Wellness Tenjin Clinic	Fukuoka-shi	Fukuoka
Japan	Matsunami Health Promotion Clinic	Hashima-gun	Gifu
Japan	Shiraiwa Medical Clinic	Kashiwara-shi	Osaka
Japan	Mikannohana Clinic, Diabetes, Endocrinology and Metabolism	Matsuyama-shi	Ehime
Japan	Nakakinen Clinic	Naka-shi	Ibaraki
Japan	Nishiyamado Keiwa Hospital	Naka-shi	Ibaraki
Japan	MIH Clinic Yoyogi	Shibuya-ku	Tokyo
Korea, Republic of	Dongguk University Ilsan Hospital	Goyang-si, Gyeonggi-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si, Gyeonggi-do
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Poland	AthleticoMed	Bydgoszcz
Poland	Centrum Badan Klinicznych PI-House Spzoo	Gdansk
Poland	AppleTreeClinics Network Spzoo	Lodz
Poland	Centrum Terapii Wspolczesnej	Lodz
Poland	Clinical Best Solutions Sp zoo Spolka Komandytowa	Lublin
Poland	Migre Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak	Wroclaw
Spain	Complexo Hospitalario Universitario A Coruña	A Coruña	Galicia
Spain	Hospital Vithas Sevilla	Castilleja de la Cuesta	Andalucía
Spain	Hospital Universitario Arnau de Vilanova Lleida	Lleida	Cataluña
Spain	Hospital Clinico Universitario Virgen de la Victoria	Malaga	Andalucía
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
United States	Research Innovations LLC dba Internal Medicine Care Inc	Beavercreek	Ohio
United States	Headlands Research Brownsville	Brownsville	Texas
United States	PanAmerican Clinical Research LLC	Brownsville	Texas
United States	Great Lakes Clinical Trials	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	The Christ Hospital	Cincinnati	Ohio
United States	Alliance for Multispecialty Research Miami	Coral Gables	Florida
United States	Medical Care LLC	Elizabethton	Tennessee
United States	East-West Medical Research	Honolulu	Hawaii
United States	Alliance for Multispecialty Research Kansas City	Kansas City	Missouri
United States	Ark Clinical Research- Long Beach	Long Beach	California
United States	Louisville Metabolic and Atherosclerosis Research Center	Louisville	Kentucky
United States	Tandem Clinical Research - Marrero	Marrero	Louisiana
United States	Alliance for Multispecialty Research Mobile	Mobile	Alabama
United States	Lucas Research	Morehead City	North Carolina
United States	Alliance for Multispecialty Research Newton	Newton	Kansas
United States	Alliance for Multispecialty Research Norman	Norman	Oklahoma
United States	Foothills Research Center	Phoenix	Arizona
United States	Progressive Medical Research	Port Orange	Florida
United States	StudyMetrix Research	Saint Peters	Missouri
United States	Clinical Trials of Texas	San Antonio	Texas
United States	Diabetes and Glandular Disease Clinic	San Antonio	Texas
United States	Pinnacle Clinical Research	San Antonio	Texas
United States	Texas Diabetes Institute	San Antonio	Texas
United States	HonorHealth	Scottsdale	Arizona
United States	State University of New York Upstate Medical University	Syracuse	New York
United States	Ark Clinical Research- Tustin	Tustin	California
United States	Orange County Research Center	Tustin	California
United States	Diablo Clinical Research	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czechia,  Germany,  Hong Kong,  Hungary,  Japan,  Korea, Republic of,  Poland,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline to Week 52 in Body Weight		Baseline and Week 52
Secondary	Percentage of Participants Achieving = 5% Reduction in Body Weight From Baseline at Week 52		Baseline and Week 52
Secondary	Percentage of Participants Achieving = 10% Reduction in Body Weight From Baseline at Week 52		Baseline and Week 52
Secondary	Achievement of = 15% Reduction in Body Weight From Baseline at Week 52		Baseline and Week 52
Secondary	Achievement of = 20% Reduction in Body Weight From Baseline at Week 52		Baseline and Week 52
Secondary	Change from Baseline to Week 52 in Hemoglobin A1c (HbA1c)		Baseline and Week 52
Secondary	Change from Baseline to Week 52 in Fasting Serum Insulin		Baseline and Week 52
Secondary	Change from Baseline to Week 52 in Fasting Plasma Glucose		Baseline and Week 52
Secondary	Change from Baseline to Week 52 in Homeostasis Model Assessment for Insulin Resistance (HOMA2-IR)		Baseline and Week 52
Secondary	Change from Baseline to Week 52 in Homeostasis Model Assessment for Steady State Beta Cell Function (HOMA2-%B)		Baseline and Week 52
Secondary	Maximum Observed Plasma Concentration (Cmax) of AMG 133		Up to Week 64
Secondary	Area Under the Concentration-time Curve (AUC) of AMG 133		Up to Week 64
Secondary	Change from Baseline to Week 52 in Waist Circumference		Baseline and Week 52
Secondary	Change from Baseline to Week 52 in Body Weight		Baseline and Week 52
Secondary	Change from Baseline to Week 52 in Systolic Blood Pressure (SBP)		Baseline and Week 52
Secondary	Change from Baseline to Week 52 in Diastolic Blood Pressure (DBP)		Baseline and Week 52
Secondary	Change from Baseline to Week 52 in Body Fat Mass Using Dual-energy X-ray Absorptiometry (DEXA)	Analyzed in a subset of participants.	Baseline and Week 52
Secondary	Change from Baseline to Week 52 in Lean Body Mass Using DEXA	Analyzed in a subset of participants.	Baseline and Week 52
Secondary	Percent Change From Baseline to Week 52 in High-sensitivity C-reactive Protein (hs-CRP)		Baseline and Week 52
Secondary	Change from Baseline to Week 52 in Body Mass Index (BMI)		Baseline and Week 52
Secondary	Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)		Baseline and Week 52
Secondary	Percent Change From Baseline in Total Cholesterol		Baseline and Week 52
Secondary	Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)		Baseline and Week 52
Secondary	Percent Change From Baseline in non-HDL-C		Baseline and Week 52
Secondary	Percent Change From Baseline in Very-low-density Lipoprotein Cholesterol (VLDL-C)		Baseline and Week 52
Secondary	Percent Change From Baseline in Triglycerides		Baseline and Week 52
Secondary	Percent Change From Baseline in Free Fatty Acids (FFA)		Baseline and Week 52

External Links

•   AmgenTrials clinical trials website