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Aleniglipron Phase 2 in Type 2 Diabetes Mellitus

NCT07400588 · Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
In plain English

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Official 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
About this study
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 criteria
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
Study design
Enrollment target: 50 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2025-12-01
Estimated completion: 2026-11
Last updated: 2026-02-10
Interventions
Drug: AleniglipronDrug: Placebo
Primary outcomes
  • Incidence, severity and relationship of AEs/SAEs (Baseline to week 38)
  • Assessment of vital signs (Baseline to week 38)
  • Assessment of laboratory measures (Baseline to week 38)
Sponsor
Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics · industry
Contacts & investigators
ContactMedical Director · contact · GSBRClinicalTrials@Structuretx.com · 650-457-1959
All locations (17)
Research SiteRecruiting
Anniston, Alabama, United States
Research SiteRecruiting
Lake Forest, California, United States
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Lomita, California, United States
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Hazelwood, Missouri, United States
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Columbus, Ohio, United States
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Moncks Corner, South Carolina, United States
Research SiteActive Not Recruiting
Chattanooga, Tennessee, United States
Research SiteNot Yet Recruiting
Knoxville, Tennessee, United States
Research SiteActive Not Recruiting
Austin, Texas, United States
Research SiteNot Yet Recruiting
Austin, Texas, United States
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DeSoto, Texas, United States
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Houston, Texas, United States
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Mesquite, Texas, United States
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San Antonio, Texas, United States
Research SiteNot Yet Recruiting
San Antonio, Texas, United States
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San Antonio, Texas, United States
Research SiteRecruiting
Tomball, Texas, United States
Aleniglipron Phase 2 in Type 2 Diabetes Mellitus · TrialPath