Clareo Health | Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hanmi Pharmaceutical Company Limited
With
Sanofi
Study duration per participant is approximately 65 weeks, including a 3-week screening period, 30 weeks core treatment period, 26 weeks extension treatment period, and 6 weeks safety follow up.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants must be at least 18 years of age at the time of signing the informed consent.
Participants with T2DM, and treated with diet and exercise.
Hemoglobin A1c between 7.0% and 10.0% (inclusive) measured by the central laboratory at Screening.
You may not be if
Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to) gastroparesis, unstable and not controlled gastroesophageal reflux disease within 6 months prior to Screening or history of surgery affecting gastric emptying.
History of pancreatitis (unless pancreatitis was related to gallstone and cholecystectomy has been performed) and pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, and pancreatectomy.
Personal or family history of Medullary Thyroidian Cancer (MTC) or genetic conditions that predisposes to MTC (eg multiple endocrine neoplasia syndromes).
Retinopathy or maculopathy with one of the following treatments, either recent (within 3 months of screening) or planned: intravitreal injections or laser or vitrectomy surgery.
Body weight change of ≥5 kg within the last 3 months prior to Screening.
End-stage renal disease as defined by estimated glomerular filtration rate (eGFR , by Modification of Diet in Renal Disease \[MDRD\]) of \<15 mL/min/1.73 m2.
Laboratory findings at the Screening Visit:
Alanine aminotransferase (ALT ) or aspartate aminotransferase (AST ) \>3 times the upper limit of the normal (ULN ) or total bilirubin \>1.5 times the ULN (except in case of documented Gilbert's syndrome).
Amylase and/or lipase: \>3 times the ULN laboratory range.
Calcitonin ≥5.9 pmol/L (20 pg/mL).
Gastric surgery or other gastric procedures intended for weight loss within 2 years prior to Screening, or planned during study period.
History of drug or alcohol abuse within 6 months prior to the time of Screening.
Pregnant (demonstrated by serum pregnancy test at Screening) or breast-feeding women.
Women of childbearing potential not willing to use highly effective method(s) of birth control during the study period and for at least 5 weeks after the last dose of study intervention.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
