Aleniglipron Phase 2 in Type 2 Diabetes Mellitus

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
Study ID
NCT07400588
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Obese
  • Obesity
  • Obesity Type 2 Diabetes Mellitus
  • Weight Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Aleniglipron — DRUG
    Drug aleniglipron administered orally
  • Placebo — DRUG
    Drug placebo administered orally

Study Details

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).

Key Dates

Start date
Dec 1, 2025
Status verified
Apr 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
58 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Participants will receive aleniglipron administered orally
    Drug aleniglipron administered orally
  • Experimental: Arm 2: Participants will receive a placebo administered orally
    Drug placebo administered orally

Primary Outcome Measure

Incidence, severity and relationship of AEs/SAEs [ Time Frame: Baseline to week 31 ]

Locations (16)

FacilityCityStateZIPSite coordinators
Research SiteAnnistonAlabama36207-
Research SiteLake ForestCalifornia92630-
Research SiteLomitaCalifornia90717-
Research SiteHazelwoodMissouri63042-
Research SiteColumbusOhio43212-
Research SiteMoncks CornerSouth Carolina29461-
Research SiteChattanoogaTennessee37421-
Research SiteKnoxvilleTennessee37909-
Research SiteAustinTexas78704-
Research SiteDeSotoTexas75115-
Research SiteHoustonTexas77079-
Research SiteMesquiteTexas75149-
Research SiteSan AntonioTexas78215-
Research SiteSan AntonioTexas78229-
Research SiteSan AntonioTexas78240-
Research SiteTomballTexas77375-

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