Phase 2 of AMG 133 in Adults With Overweight or Obesity, With or Without Type 2 Diabetes
Research type
Research Study
Full title
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
IRAS ID
1006734
Contact name
Matthew Rodaway
Contact email
Sponsor organisation
Amgen Inc.
Eudract number
2022-002470-86
Research summary
Obesity is defined as abnormal or excessive fat accumulation that presents a risk to health and is a major risk factor for type 2 diabetes mellitus, cardiovascular disease, and several other complications, resulting in reduced life expectancy.
Weight loss has a major beneficial impact on overweight- and obesity-related complications.
The medicine being tested in this study, AMG 133 is being developed by Amgen Inc. AMG 133 acts on the receptors for two hormones released by gut in response to food intake, that is, glucagon-like peptide-1 (GLP-1), which inhibits appetite and improves glucose regulation in patients with type 2 diabetes (T2DM), and glucose-dependent insulinotropic polypeptide (GIP), which can increase the amount of fat stored in body. By activating the GLP-1 receptor and blocking the GIP receptor, AMG 133 is expected to help weight loss.
This research study is being conducted to see if different doses of AMG 133 are effective, safe, and tolerable in people with overweight or obesity with or without type 2 diabetes.
The effects of AMG 133 will be compared with a placebo. A placebo is a substance that looks identical to the treatment being tested but does not contain active ingredients and has no medical effect.
Approximately 42 people from UK are expected to participate in this research study.
Participants will receive AMG 133 or placebo every 4 weeks during the visits in clinic, in the form of 3 injections under the skin in the area around belly. Treatment will take up to 13 months.
During the visits in clinic, participants will have routine procedures performed (like measurement of body temperature, weight, heart rate, blood pressure, sometimes ECG), they will also have blood taken for laboratory tests, fill a few questionnaires and receive advice on physical activity and nutrition.
All participants will measure weight at home, and those with diabetes will take blood glucose reading, and record the results in a diary.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
23/SC/0023
Date of REC Opinion
7 Dec 2023
REC opinion
Further Information Unfavourable Opinion