Aleniglipron Phase 2 in Type 2 Diabetes Mellitus

Condition(s) studied

Investigational drug(s) / intervention(s)

Aleniglipron: Drug aleniglipron administered orally

Placebo: Drug placebo administered orally

Study summary

The purpose of this study is to assess the safety and tolerability of aleniglipron at doses up to 240 mg once daily (QD) in participants with T2DM who are living with obesity (body mass index \[BMI\] ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2).

Eligibility

Primary outcome measure(s)

• Incidence, severity and relationship of AEs/SAEs — Baseline to week 31
• Assessment of vital signs — Baseline to week 31
  Number of Participants with Clinically Significant Change from Baseline in Vital Signs: including Systolic and Diastolic Blood Pressure, Heart Rate, and temperature.
• Assessment of laboratory measures — Baseline to week 31
  Number of Participants with Clinically Significant Change from Baseline in Laboratory Parameters: including hematology, serum chemistry, coagulation
• Assessment of Electrocardiograms (ECG) — Baseline to week 31
  Number of Participants with Clinically Significant Change from Baseline in Electrocardiogram (ECG) Parameters: Common ECG-related variables will be assessed, including but not limited to: ventricular heart rate, PR interval, QRS duration, QT interval, and QTcF

Trial sites (16)

More Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics trials in the USA

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