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NCT Number: NCT07400588

Aleniglipron Phase 2 in Type 2 Diabetes Mellitus

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Obese Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity Type 2 Diabetes Mellitus Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Anniston, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed Informed Consent
  • A diagnosis of T2DM of ≥6 months,
  • Hemoglobin A1c (HbA1c) ≥6.5% to ≤10% at Screening
  • Have a BMI ≥27.0 kg/m2

Exclusion criteria

  • Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema. All participants must have a photo fundoscopy, optical coherence tomography, or slit lamp assessment prior to randomization and within the last 12 months to confirm the absence or stable status of diabetic retinopathy and/or macular edema.
  • Present or planned use of any drug that could interfere with glucose levels
  • Self-reported change in body weight >5 kg (11 pounds) within 3 months before screening
  • Have prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year prior to Screening)
  • Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to Screening, including, but not limited to, mucosal ablation, gastric artery embolization, intragastric balloon, and duodenal-jejunal endoluminal liner

Treatment and study plan

Aleniglipron

Drug

Drug aleniglipron administered orally

Placebo

Drug

Drug placebo administered orally

Primary outcomes

  1. Incidence, severity and relationship of AEs/SAEs

    Time frame: Baseline to week 31

  2. Assessment of vital signs

    Time frame: 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.

  3. Assessment of laboratory measures

    Time frame: Baseline to week 31

    Number of Participants with Clinically Significant Change from Baseline in Laboratory Parameters: including hematology, serum chemistry, coagulation

  4. Assessment of Electrocardiograms (ECG)

    Time frame: 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

Secondary outcomes

  1. Absolute change in body weight from Baseline

    Time frame: Baseline to week 31

  2. Percent change in body weight from Baseline

    Time frame: Baseline to week 31

  3. Change in HbA1c from Baseline

    Time frame: Baseline to week 30

  4. Change in fasting plasma glucose from Baseline

    Time frame: Baseline to week 31

  5. PK parameters including but not limited to AUC

    Time frame: Baseline to week 30

  6. PK parameters including but not limited to Cmax

    Time frame: Baseline to week 30

  7. PK parameters including but not limited to Tmax

    Time frame: Baseline to week 30

  8. PK parameters including but not limited to Ctrough

    Time frame: Baseline to week 30

Sponsors and collaborators

Lead sponsor

Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-blind, Placebo-controlled, Study of the Safety and Tolerability of Aleniglipron in Adult Participants With Type 2 Diabetes Mellitus Living With Obesity or Overweight

Acronym: GSBR-1290

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2026
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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