Clinical Trials List
Protocol Number20190218
NCT Number(ClinicalTrials.gov Identfier)NCT05669599
2023-01-30 - 2024-12-29
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
2025/08/20
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
- Chun-Yuan Chu Division of Cardiovascular Diseases
- 卓士傑 Division of Cardiovascular Diseases
- 吳韋璁 Division of Cardiovascular Diseases
- Po-Chao Hsu Division of Cardiovascular Diseases
- Ye-Hsu Lu Division of Cardiovascular Diseases
- 黃天祈 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 張尹凡 Division of Family Medicine
- Horng-Yih Ou Division of General Internal Medicine
- 林景翰 Division of General Internal Medicine
- 杜業豐 Division of General Internal Medicine
- 吳至行 Division of Family Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Type 2 Diabetes Mellitus、Obesity、Overweight
Objectives
This is a Phase 2, double-blind, dose-varying, placebo-controlled trial evaluating the efficacy, safety, and tolerability of AMG 133 in overweight or obese adult subjects, regardless of whether they have diabetes. Cohort A will include subjects with undiagnosed type 1 or type 2 diabetes, while cohort B will include subjects with confirmed type 2 diabetes.
main target:
• Comparison and evaluation of 3 selected compared to placebo in overweight or obese subjects without diabetes (Group A) and in overweight or obese subjects with diabetes (Group B) Dose-response of AMG 133 to induce and maintain weight loss from baseline to week 52
Major secondary goals:
• To evaluate the effect of AMG 133 on achieving category-specific weight loss from baseline to week 52 in Group A and Group B
• Evaluation of the effect of AMG 133 on glucose metabolism in Population A and Population B
• Exploring the pharmacokinetic (PK) properties of AMG 133
Test Drug
AMG133
Active Ingredient
AMG133
Dosage Form
SC Injection
Dosage
70
Endpoints
main target
-Change in body weight percentage from baseline to week 52
major secondary goals
- Weight loss of ≥ 5% from baseline at week 52 (yes/no)
- Weight loss of ≥ 10% from baseline at week 52 (yes/no)
- Weight loss of ≥ 15% from baseline at week 52 (yes/no)
-20% weight loss from baseline at week 52 (yes/no)
secondary goals
-Change in waist circumference from baseline to week 52
-Change in body weight from baseline to week 52
-SBP change from baseline to week 52
-DBP change from baseline to week 52
-Measurement of changes in total and regional visceral fat and net body weight in subgroups of subjects from baseline to week 52 using dual-energy X-ray absorptiometry (DEXA)
-Percent change in high-sensitivity C-reactive protein (hs-CRP) from baseline
-Change in BMI from baseline to week 52
-Percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to week 52
-Percent change in total cholesterol from baseline to week 52
-Percent change in high-density lipoprotein cholesterol (HDL-C) from baseline to week 52
-Non-HDL-C Percent change from baseline to week 52
-Percent change in very low-density lipoprotein cholesterol (VLDL-C) from baseline to week 52
-Percent change in triglycerides from baseline to week 52
-Percent change in free fatty acids (FFA) from baseline to week 52
-Change in body weight percentage from baseline to week 52
major secondary goals
- Weight loss of ≥ 5% from baseline at week 52 (yes/no)
- Weight loss of ≥ 10% from baseline at week 52 (yes/no)
- Weight loss of ≥ 15% from baseline at week 52 (yes/no)
-20% weight loss from baseline at week 52 (yes/no)
secondary goals
-Change in waist circumference from baseline to week 52
-Change in body weight from baseline to week 52
-SBP change from baseline to week 52
-DBP change from baseline to week 52
-Measurement of changes in total and regional visceral fat and net body weight in subgroups of subjects from baseline to week 52 using dual-energy X-ray absorptiometry (DEXA)
-Percent change in high-sensitivity C-reactive protein (hs-CRP) from baseline
-Change in BMI from baseline to week 52
-Percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to week 52
-Percent change in total cholesterol from baseline to week 52
-Percent change in high-density lipoprotein cholesterol (HDL-C) from baseline to week 52
-Non-HDL-C Percent change from baseline to week 52
-Percent change in very low-density lipoprotein cholesterol (VLDL-C) from baseline to week 52
-Percent change in triglycerides from baseline to week 52
-Percent change in free fatty acids (FFA) 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
17 participants
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Global
570 participants
