Clareo Health | 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
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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Lead
Amgen
Age
18–99
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
