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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.
EU CTIS ID: 2023-510470-13-00
What this study is testing
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 subjects with overweight or obesity without diabetes mellitus (cohort A) and in subjects with overweight or obesity with type 2 diabetes mellitus (cohort B)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
- Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
- Subject has a BMI ≥ 27 kg/sq.m at screening
- Subject has had at least 1 unsuccessful attempt at weight loss by diet and exercise in the opinion of the investigator.
- For subjects in cohort A only, presence of at least 1 of the following weight-related complications: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease; or BMI ≥ 30 kg/sq.m
- For subjects in cohort A only, HbA1c < 6.5% (< 48 mmol/mol) at screening without a diagnosis of type 1 or 2 diabetes mellitus.
You likely can't join if
- 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).
- History of proliferative diabetic retinopathy, diabetic macular edema, or nonproliferative diabetic retinopathy that requires acute treatment.
- For the subjects in the DXA substudy only, body weight greater than the local DXA scanner capacity at screening.
- Change in body weight > 5 kg within 90 days before screening per subject report or medical records.
- For subjects in cohort B only, fasting glucose > 270 mg/dL (15.0 mmol/L) at screening.
- 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.
See the full eligibility criteria
- Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
- Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
- Subject has a BMI ≥ 27 kg/sq.m at screening
- Subject has had at least 1 unsuccessful attempt at weight loss by diet and exercise in the opinion of the investigator.
- For subjects in cohort A only, presence of at least 1 of the following weight-related complications: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease; or BMI ≥ 30 kg/sq.m
- For subjects in cohort A only, HbA1c < 6.5% (< 48 mmol/mol) at screening without a diagnosis of type 1 or 2 diabetes mellitus.
- For subjects 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.
- For subjects in cohort B only, 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.
- 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).
- History of proliferative diabetic retinopathy, diabetic macular edema, or nonproliferative diabetic retinopathy that requires acute treatment.
- For the subjects in the DXA substudy only, body weight greater than the local DXA scanner capacity at screening.
- Change in body weight > 5 kg within 90 days before screening per subject report or medical records.
- For subjects in cohort B only, fasting glucose > 270 mg/dL (15.0 mmol/L) at screening.
- 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.
- 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.
- A corrected QT interval (QTc) of > 450 msec in males or > 470 msec in females at screening as assessed by the investigator, or history of long QT syndrome
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- Australia
- United States
- Hong Kong
- Japan
- Canada
- Korea, Republic of
- China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiwan; Australia; United States; Hong Kong; Japan; Canada and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.