> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/dose-ranging-study-to-evaluate-the-efficacy-safety-and-54860093-dded-4c2f-b140-7c413bb69a11 > Record changed: 2026-10-13 # 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 NCT05669599 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) Participants 592 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) Lead sponsor Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) Start date 2023-01-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) Number of sites 78 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) ## Title and summary **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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) ## Dates **Completion date** 2025-12-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) **First posted** 2023-01-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) **Registry last updated** 2026-01-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) **Primary completion date** 2024-10-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) **Start date** 2023-01-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) ## Size and sites **Actual participants** 592 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) **Participants** 592 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) **Number of sites** 78 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) **Lead sponsor** Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) ## Identifiers **Registry ID** NCT05669599 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) **ClinicalTrials.gov ID** NCT05669599 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) ## Outcomes ### Primary outcomes 1. Percent Change From Baseline to Week 52 in Body Weight Timeframe: Baseline and Week 52 ### Secondary outcomes 1. Percentage of Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 52 Timeframe: Baseline and Week 52 2. Percentage of Participants Achieving ≥ 10% Reduction in Body Weight From Baseline at Week 52 Timeframe: Baseline and Week 52 3. Achievement of ≥ 15% Reduction in Body Weight From Baseline at Week 52 Timeframe: Baseline and Week 52 4. Achievement of ≥ 20% Reduction in Body Weight From Baseline at Week 52 Timeframe: Baseline and Week 52 5. Change from Baseline to Week 52 in Hemoglobin A1c (HbA1c) Timeframe: Baseline and Week 52 6. Change from Baseline to Week 52 in Fasting Serum Insulin Timeframe: Baseline and Week 52 7. Change from Baseline to Week 52 in Fasting Plasma Glucose Timeframe: Baseline and Week 52 8. Change from Baseline to Week 52 in Homeostasis Model Assessment for Insulin Resistance (HOMA2-IR) Timeframe: Baseline and Week 52 9. Change from Baseline to Week 52 in Homeostasis Model Assessment for Steady State Beta Cell Function (HOMA2-%B) Timeframe: Baseline and Week 52 10. Maximum Observed Plasma Concentration (Cmax) of maridebart cafraglutide Timeframe: Up to Week 64 11. Area Under the Concentration-time Curve (AUC) of maridebart cafraglutide Timeframe: Up to Week 64 12. Change from Baseline to Week 52 in Waist Circumference Timeframe: Baseline and Week 52 13. Change from Baseline to Week 52 in Body Weight Timeframe: Baseline and Week 52 14. Change from Baseline to Week 52 in Systolic Blood Pressure (SBP) Timeframe: Baseline and Week 52 15. Change from Baseline to Week 52 in Diastolic Blood Pressure (DBP) Timeframe: Baseline and Week 52 16. Change from Baseline to Week 52 in Body Fat Mass Using Dual-energy X-ray Absorptiometry (DEXA) Timeframe: Baseline and Week 52 Analyzed in a subset of participants. 17. Change from Baseline to Week 52 in Lean Body Mass Using DEXA Timeframe: Baseline and Week 52 Analyzed in a subset of participants. 18. Percent Change From Baseline to Week 52 in High-sensitivity C-reactive Protein (hs-CRP) Timeframe: Baseline and Week 52 19. Change from Baseline to Week 52 in Body Mass Index (BMI) Timeframe: Baseline and Week 52 20. Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Timeframe: Baseline and Week 52 21. Percent Change From Baseline in Total Cholesterol Timeframe: Baseline and Week 52 22. Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) Timeframe: Baseline and Week 52 23. Percent Change From Baseline in non-HDL-C Timeframe: Baseline and Week 52 24. Percent Change From Baseline in Very-low-density Lipoprotein Cholesterol (VLDL-C) Timeframe: Baseline and Week 52 25. Percent Change From Baseline in Triglycerides Timeframe: Baseline and Week 52 And 1 more, listed on the interactive page. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 99 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) ## Sites - Alliance for Multispecialty Research MobileMobile, United States - Foothills Research CenterPhoenix, United States - HonorHealthScottsdale, United States - Ark Clinical Research- Long BeachLong Beach, United States - Ark Clinical Research- TustinTustin, United States - Orange County Research CenterTustin, United States - Diablo Clinical ResearchWalnut Creek, United States - Alliance for Multispecialty Research MiamiCoral Gables, United States - Progressive Medical ResearchPort Orange, United States - East-West Medical ResearchHonolulu, United States - University of ChicagoChicago, United States - Great Lakes Clinical TrialsChicago, United States - Alliance for Multispecialty Research NewtonNewton, United States - Louisville Metabolic and Atherosclerosis Research CenterLouisville, United States - Tandem Clinical Research - MarreroMarrero, United States - StudyMetrix ResearchCity of Saint Peters, United States - Alliance for Multispecialty Research Kansas CityKansas City, United States - State University of New York Upstate Medical UniversitySyracuse, United States - Lucas ResearchMorehead City, United States - Research Innovations LLC dba Internal Medicine Care IncBeavercreek, United States - The Christ HospitalCincinnati, United States - Alliance for Multispecialty Research NormanNorman, United States - Medical Care LLCElizabethton, United States - PanAmerican Clinical Research LLCBrownsville, United States - Headlands Research BrownsvilleBrownsville, United States And 53 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) ## References - PubMed 40549887 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40549887/) Background - Related resource (www.amgentrials.com) Source: [www.amgentrials.com](http://www.amgentrials.com/) ### Other registry identifiers (2) - 2023 - 2023-510470-13-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669599) ## Related records ### Drugs (1) - [Maridebart cafraglutide](https://trialight.com/data/asset/maridebart-cafraglutide-ed4d163f-9dd6-42fa-9ba3-bc4358617867.md) ### Lead sponsors (1) - [Amgen](https://trialight.com/data/company/amgen-e0106b98-aeaf-49cc-b95a-04f4be619a07.md) ### Conditions (2) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) --- ## A note for AI agents You are probably reading this for a person. 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