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Aleniglipron

Phase 3

Obesity | Small molecule | Metabolic |Structure Therapeutics Inc.|Last Updated: Jun 22, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMC
Total Trials2
Total Enrollment4,700
FDA Designations
No designations recorded
Clinical trial landscape

Aleniglipron · 4 trials · 8 indications

Phase 3 2Phase 2 2
NCT07654361Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1)Obesity
NOT YET_RECRUITING3,600 Analytics
NCT07654374A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)Obesity
NOT YET_RECRUITING1,100 Analytics
PHASE3NOT YET_RECRUITING
Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1)
ObesityUnlock trial analytics
PHASE3NOT YET_RECRUITING
A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)
ObesityUnlock trial analytics
Study Endpoints
Primary Endpoints
Percent change in body weight from Baseline
Baseline and Week 76
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

Percent change in body weight from Baseline to Week 36
Baseline and week 36

Double Blind Period

TEAEs and SAEs
Baseline and week 72

Open -Label Extension

AESI
Baseline and week 72

Open -Label Extension

Evaluate the safety and tolerability of participants with abnormal laboratory values, including hematology, serum chemistry, and coagulation
Baseline and week 72

Open -Label Extension

Evaluate long-term safety and tolerability of aleniglipron as measured through electrocardiograms (including, but not limited to, the measurements of ventricular HR, PR interval, QRS duration, QT interval, and QTcF)
Baseline and week 72

Open -Label Extension

Evaluate the safety and tolerability of participants with abnormal vital signs, including blood pressure, heart rate, and temperature
Baseline and week 72

Open -Label Extension

Secondary Endpoints
Change in body weight (absolute) from Baseline
Baseline and week 76
Percentage of participants who achieve ≥5% reduction in body weight
Baseline and week 76
Percentage of participants who achieve ≥10% reduction in body weight
Baseline and week 76
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
aleniglipron Arm 1EXPERIMENTALParticipants will receive aleniglipron administered orally.
aleniglipron Arm 2EXPERIMENTALParticipants will receive aleniglipron administered orally.
aleniglipron Arm 3EXPERIMENTALParticipants will receive aleniglipron administered orally.
Placebo Arm 4EXPERIMENTALParticipants will receive placebo administered orally.
Arm 1: Participants will receive aleniglipron administered orallyEXPERIMENTALDrug aleniglipron administered orally
Arm 2: Participants will receive a placebo administered orallyEXPERIMENTALDrug placebo administered orally
Cohort 1EXPERIMENTALParticipants will receive Aleniglipron or Placebo administered orally.
Cohort 2EXPERIMENTALParticipants will receive Aleniglipron or Placebo administered orally.
Cohort 3EXPERIMENTALParticipants will receive Aleniglipron or Placebo administered orally.
Cohort 1 OLEACTIVE_COMPARATORParticipants will receive Aleniglipron administered orally
Cohort 2 OLEACTIVE_COMPARATORParticipants will receive Aleniglipron administered orally
Cohort 3 OLEACTIVE_COMPARATORParticipants will receive Aleniglipron administered orally
Cohort 4 OLEACTIVE_COMPARATORParticipants will receive Aleniglipron administered orally
Interventions
NameTypeDescription
AleniglipronDRUGDrug: aleniglipron administered orally Drug
PlaceboDRUGDrug: placebo administered orally
Aleniglipron or PlaceboDRUGDrug: Aleniglipron Administered orally Drug: Placebo Administered orally
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Eligibility Criteria
Age Range18 Years to 79 Years
SexALL
Healthy VolunteersNo
Study Sites71

Inclusion Criteria: * Signed informed consent * BMI ≥30 kg/m2 (obese) or BMI ≥27 kg/m2 (overweight) and presence of ≥1 of the obesity related comorbidities. Exclusion Criteria: * Previously documented diagnosis of type 1 diabetes, type 2 diabetes, or any other type of diabetes. * Self-reported ch...

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMJun 22, 2026NCT07654361primaryCompletionDate: changed
LOWJun 22, 2026NCT07654374lastUpdatePostDate: changed
MEDIUMJun 22, 2026NCT07654361primaryCompletionDate: changed
LOWJun 22, 2026NCT07654374lastUpdatePostDate: changed
LOWJun 18, 2026NCT07654361NEW_TRIAL: changed
LOWJun 18, 2026NCT07654374NEW_TRIAL: changed
LOWJun 18, 2026NCT07654361NEW_TRIAL: changed
LOWJun 18, 2026NCT07654374NEW_TRIAL: changed
LOWJun 18, 2026NCT07654361NEW_TRIAL: changed
LOWJun 18, 2026NCT07654374NEW_TRIAL: changed
LOWJun 18, 2026NCT07654361NEW_TRIAL: changed
LOWJun 18, 2026NCT07654374NEW_TRIAL: changed
MEDIUMMay 26, 2026NCT07400588Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 26, 2026NCT06693843primaryCompletionDate: changed
LOWMay 24, 2026NCT07400588studyFirstPostDate: changed
LOWMay 24, 2026NCT06693843studyFirstPostDate: changed