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.

Phase 1

• Conditions: Overweight and Obesity; MedDRA version: 24.1Level: PTClassification code: 10033307Term: Overweight Class: 100000004861; MedDRA version: 20.0Level: PTClassification code: 10029883Term: Obesity Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: CTIS2023-510470-13-00
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-03
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 592

Inclusion 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.

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)., 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified