Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin

Study duration per participant is approximately 65 weeks including an up to 3-week Screening
Period, a 56-week Treatment Period and a 6-week safety Follow-up Period.

Inclusion criteria:

- Participant must be ≥18 years of age at the time of signing the informed consent

- Participants with Type 2 diabetes mellitus (T2DM)

- Diabetes diagnosed at least 1 year before screening

- Participants on stable dose of at least 1500 mg/day of metformin, or tolerated maximum
dose, or as per country regulation if less, for at least 3 months prior to screening

- Glycated hemoglobin (HbA1c) between 7.0% and 10.0% (inclusive) measured by the central
laboratory at screening

Exclusion criteria:

- Retinopathy or maculopathy with one of the following treatments, either recent (within
3 months prior to screening) or planned: intravitreal injections or laser or
vitrectomy surgery

- Clinically relevant history of gastrointestinal (GI) disease associated with prolonged
nausea and vomiting, including (but not limited to) gastroparesis, unstable and not
controlled gastroesophageal reflux disease requiring medical treatment within 6 months
prior to screening or history of surgery affecting gastric emptying

- History of pancreatitis (unless pancreatitis was related to gallstones and
cholecystectomy has been performed), pancreatitis during previous treatment with
incretin therapies, chronic pancreatitis, pancreatectomy

- Personal or family history of medullary thyroid cancer (MTC) or genetic conditions
that predisposes to MTC (e.g., multiple endocrine neoplasia syndromes)

- 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

- Severe renal disease as defined by estimated glomerular filtration rate (eGFR, by
Modification of Diet in Renal Disease [MDRD]) of <30 mL/min/1.73 m2

- Laboratory findings at the screening visit:

- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × ULN or total
bilirubin >1.5 × ULN (except in case of documented Gilbert's syndrome);

- Amylase and/or lipase: >3 x ULN;

- 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

- Pregnant (confirmed by serum pregnancy test at screening) or breast-feeding women

- Women of childbearing potential (WOCBP) not willing to use highly effective method(s)
of birth control or who are unwilling to be tested for pregnancy 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.