Lay Description

This is a phase 2, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy, safety, and tolerability of AMG 133 in adult subjects with overweight or obesity, with and without diabetes mellitus. Cohort A will consist of subjects without a diagnosis of type 1 or type 2 diabetes mellitus, and cohort B will consist of subjects with a diagnosis of type 2 diabetes mellitus.


  • Diabetes
  • Healthy Subjects Needed
IRB Number
NCT Number registration not required
Open to Enrollment


Eligible Ages
18 years and up
Eligible Genders
Accepts Healthy Volunteers

Inclusion Criteria

Eligible subjects for cohort A will have a BMI ≥ 30 kg/m2 or  27 kg/m2 with the presence of at least 1 of the following weight-related complications: hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease; and will have HbA1c < 6.5% (< 48 mmol/mol) at screening, without a diagnosis of type 1 or 2 diabetes mellitus.

Eligible subjects for cohort B will have a BMI  27 kg/m2; an HbA1c  7% and ≤ 10% (53 to 86 mmol/mol) at screening; and an established diagnosis of type 2 diabetes mellitus for ≥ 180 days prior to screening and either be treated with diet and exercise alone or be on stable treatment (at least 90 days prior to screening) with metformin, a sulfonylurea, or a sodium-glucose cotransporter 2 (SGLT2) inhibitor as monotherapy or combination therapy, per approved local label.

Exclusion Criteria

Subjects with type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except type 2 diabetes mellitus (for cohort B only).

202 History of proliferative diabetic retinopathy, diabetic macular edema, or nonproliferative diabetic retinopathy that requires acute treatment

Any of the following within the last 6 months prior to screening: myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack, cerebrovascular accident, or decompensated congestive heart failure; or currently have New York Health Association Class III or IV heart failure 207 Malignancy except nonmelanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years.

208 Uncontrolled thyroid disease, defined as TSH > 6.0 mIU/L or < 0.4 mIU/L as measured by central laboratory at screening. Subjects who received treatment for hypothyroidism are permitted in the study, if their thyroid hormone replacement dose has been stable for at least 90 days and their TSH at screening is within the above range.

Study Design

Arm Groups

Study Contact

Andrea Hansis-diarte
+1 (210) 617-5300

Principal Investigator
Ralph DeFronzo