Clinical Trials List
Protocol Number20190218
NCT Number(ClinicalTrials.gov Identfier)NCT05669599
Active
2023-01-30 - 2026-01-26
Phase II
Recruiting4
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
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Hua-Shui Hsu Division of Family Medicine
- 陳宗伯 Division of Family Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 卓士傑 Division of Cardiovascular Diseases
- Ye-Hsu Lu Division of Cardiovascular Diseases
- 吳韋璁 Division of Cardiovascular Diseases
- 黃天祈 Division of Cardiovascular Diseases
- Chun-Yuan Chu Division of Cardiovascular Diseases
- Po-Chao Hsu Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Yi-Ching Yang
Co-Principal Investigator
- 林景翰 Division of General Internal Medicine
- 杜業豐 Division of General Internal Medicine
- 張尹凡 Division of Family Medicine
- 吳至行 Division of Family Medicine
- Horng-Yih Ou Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Obesity
Objectives
This is a phase II, double-blind, dose-unequal, placebo-controlled trial evaluating the efficacy, safety, and tolerability of AMG 133 in overweight or obese adults, regardless of whether they have diabetes. Group A will include participants without a confirmed type 1 or type 2 diabetes diagnosis, while Group B will include participants with a confirmed type 2 diabetes diagnosis.
Primary Objectives:
• To compare and evaluate the dose-response to placebo in overweight or obese participants without diabetes (Group A) and overweight or obese participants with diabetes (Group B), emphasizing the effect of three selected doses of AMG 133 on weight loss from baseline to week 52.
Major Secondary Objectives:
• To evaluate the effect of AMG 133 on achieving specific categories of weight loss from baseline to week 52 in Groups A and B.
• To evaluate the effect of AMG 133 on glucose metabolism in Groups A and B.
• To investigate the pharmacokinetic (PK) characteristics of AMG 133.
Test Drug
皮下注射劑
Active Ingredient
AMG133
Dosage Form
220
Dosage
70mg, 140mg, 420mg
Endpoints
Primary Objective
- Change in body weight percentage from baseline to week 52
Major Secondary Objectives
- Weight reduction of ≥ 5% from baseline at week 52 (Yes/No)
- Weight reduction of ≥ 10% from baseline at week 52 (Yes/No)
- Weight reduction of ≥ 15% from baseline at week 52 (Yes/No)
- Weight reduction of ≥ 20% from baseline at week 52 (Yes/No)
Secondary Objectives
- Waist circumference change from baseline to week 52
- Weight change from baseline to week 52
- SBP change from baseline to week 52
- DBP change from baseline to week 52
- Change in total fat, visceral fat, and net weight of the subject subgroup from baseline to week 52 using dual-energy X-ray absorptiometry (DEXA)
- High-sensitivity C-reactive protein (hs-CRP) Percentage change from baseline
-BMI Change from baseline to week 52
-Low-density lipoprotein cholesterol (LDL-C) Percentage change from baseline to week 52
-Total cholesterol Percentage change from baseline to week 52
-High-density lipoprotein cholesterol (HDL-C) Percentage change from baseline to week 52
-Non-HDL-C Percentage change from baseline to week 52
-Very low-density lipoprotein cholesterol (VLDL-C) Percentage change from baseline to week 52
-Triglycerides Percentage change from baseline to week 52
-Free fatty acids (FFA) Percentage change from baseline to week 52
- Change in body weight percentage from baseline to week 52
Major Secondary Objectives
- Weight reduction of ≥ 5% from baseline at week 52 (Yes/No)
- Weight reduction of ≥ 10% from baseline at week 52 (Yes/No)
- Weight reduction of ≥ 15% from baseline at week 52 (Yes/No)
- Weight reduction of ≥ 20% from baseline at week 52 (Yes/No)
Secondary Objectives
- Waist circumference change from baseline to week 52
- Weight change from baseline to week 52
- SBP change from baseline to week 52
- DBP change from baseline to week 52
- Change in total fat, visceral fat, and net weight of the subject subgroup from baseline to week 52 using dual-energy X-ray absorptiometry (DEXA)
- High-sensitivity C-reactive protein (hs-CRP) Percentage change from baseline
-BMI Change from baseline to week 52
-Low-density lipoprotein cholesterol (LDL-C) Percentage change from baseline to week 52
-Total cholesterol Percentage change from baseline to week 52
-High-density lipoprotein cholesterol (HDL-C) Percentage change from baseline to week 52
-Non-HDL-C Percentage change from baseline to week 52
-Very low-density lipoprotein cholesterol (VLDL-C) Percentage change from baseline to week 52
-Triglycerides Percentage change from baseline to week 52
-Free fatty acids (FFA) Percentage change from baseline to week 52
Inclution 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.
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
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.
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.
The Estimated Number of Participants
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Taiwan
18 participants
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Global
570 participants
