XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)

Part A - SAD, including FE cohort: Healthy participants with BMI in the range of ≥18.5 kg/m2 to ≤35.0 kg/m2 will be randomized to receive a single oral dose of either XW014 or placebo in each of the planned SAD cohorts.

Part B and Part B-EXT - MAD in healthy participants with elevated BMI: Healthy subjects with BMI in the range of ≥30 kg/m2 to ≤40.0 kg/m2 will be randomized to receive oral doses of XW014 or placebo in each of the planned MAD cohorts.

Part C - MAD in patients with T2DM: Patients with T2DM for at least 6 months, having hemoglobin A1c (HbA1c) in the range of 6.5% to 8.5% will be randomized to receive oral doses of XW014 or placebo in each of the planned MAD cohorts.

Inclusion criteria

• Ability and willingness to participate in the study, give written informed consent, and comply with the study restrictions and all protocol procedures
• Sex: male or female
• Weight: >50 kg, inclusive, at screening
• Age:

• For Part A 18 to 70 years, inclusive, at screening
• For Part B, Part B-EXT, and C 18 to 55 years, inclusive, at screening
• Body Mass Index

• For Part A: ≥18.5 kg/m2 and ≤35.0 kg/m2, inclusive, at screening
• For Part B and Part B-EXT: ≥30.0 kg/m2 and ≤40.0 kg/m2, inclusive, at screening
• For Part C: ≥25.0 kg/m2 and ≤40.0 kg/m2, inclusive, at screening
• Patients with T2DM for at least 6 months, having HbA1c of 6.5% to 8.5% (Part C)

Key Exclusion Criteria:

• History or clinically significant active disease of the gastrointestinal, cardiovascular, hepatic, neurologic, renal, pancreatic, immunologic, dermatologic, endocrine, genitourinary, or hematologic system
• Uncontrolled hypertension
• History of type 1 diabetes mellitus
• History or current diagnosis of acute or chronic pancreatitis or factors for pancreatitis
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 or subjects with suspected medullary thyroid carcinoma
• Existence of any surgical or medical condition that, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism, or excretion of the investigational product