Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise

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.

Inclusion criteria:

- 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.

Exclusion criteria:

- 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.

- Systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg at
Randomization.

- 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.