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xMedica

NCT07654374ClinicalTrials.gov

A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)

A Long-Term Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Multiple Maintenance Doses of Oral Once Daily Aleniglipron for Chronic Weight Management in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.
יצירת קשר עם המחקר

בקצרה

This is randomized, double-blind, placebo-controlled study of the long-term efficacy, safety, and tolerability of multiple doses of aleniglipron in participants living with overweight or obesity and T2DM. Participants will be randomized to aleniglipron or placebo for a total of 76…

שלב 3דרושים 1,100 משתתפים74 אתריםמדינה אחת

קטגוריות

רשום במרשם אחד

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Present: Registered before enrolment beganFirst posted 2026-06-17; recorded start 2026-07-17
  • Present: Has a defined primary outcomeA primary outcome measure is listed in the record
  • Present: The primary outcome states a time frameThe primary outcome measure records a time frame
  • Present: Participants are randomly assignedAllocation is recorded as randomised
  • Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Present: Uses blinding (masking)A masking level is recorded in the record
  • Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Present: Sponsor has 5 other studies in this databaseCounted from the lead sponsor named in the record (Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics)
  • Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
  • The record lists 4 conditions.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding16/20

    Triple-blind

  • Control arm13/15

    Placebo / sham control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 74 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study: 1,100 participants (target), run at 74 sites.

How this score is built
  • Enrolment30/40

    1,100 participants (target)

  • Site count21/25

    74 sites

  • Country count0/15

    Single country

  • Planned duration7/10

    Planned over about 28 months

  • Sponsor scale2/10

    Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics has led 6 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

תקציר

This is randomized, double-blind, placebo-controlled study of the long-term efficacy, safety, and tolerability of multiple doses of aleniglipron in participants living with overweight or obesity and T2DM. Participants will be randomized to aleniglipron or placebo for a total of 76 weeks of treatment.

מצבים רפואיים

  • Obesity
  • Overweight
  • Chronic Weight Management
  • Type2 Diabetes Mellitus

זכאות

זכאות
מיןהכול
גילאים18 Years79 Years
מתנדבים בריאיםכן

זכאות כפי שנכתבה במרשם

Inclusion Criteria: * Signed Informed Consent * Have a BMI ≥27.0 kg/m2 at Screening * Have a diagnosis of T2DM according to the WHO classification or other locally applicable standards, with HbA1c ≥6.5% (≥53 mmol/mol) to ≤10% (86 mmol/mol) at Screening Exclusion Criteria: * Have type 1 diabetes, history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM. * Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 180 days prior to Screening. * Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema * Self-reported change in body weight \>5 kg (11 pounds) within 3 months before Screening. * Have prior or planned surgical or non-surgical treatment for obesity.

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

תכנון המחקר
סוג המחקרהתערבותי
שלבשלב 3
הקצאהאקראי
מודל ההתערבותPARALLEL
מטרה ראשיתTREATMENT
הסתרהTRIPLE (3)
גיוסדרושים 1,100 משתתפים

נותן חסות ושותפים

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

זרועות והתערבויות

  • aleniglipron Arm 1EXPERIMENTAL

    Participants will receive aleniglipron administered orally.

  • aleniglipron Arm 2EXPERIMENTAL

    Participants will receive aleniglipron administered orally.

  • aleniglipron Arm 3EXPERIMENTAL

    Participants will receive aleniglipron administered orally.

  • Placebo Arm 4PLACEBO_COMPARATOR

    Participants will receive placebo administered orally.

התערבויות

  • תרופה Placebo

    Drug: placebo administered orally

  • תרופה aleniglipron

    Drug: aleniglipron administered orally

  • תרופה aleniglipron

    Drug: aleniglipron administered orally

  • תרופה aleniglipron

    Drug: aleniglipron administered orally

מדדי תוצאה

  1. מדד תוצאה ראשוני

    Percent change in body weight from Baseline

    מסגרת זמן Baseline and week 76

  2. מדד תוצאה משני

    Percentage of participants achieving HbA1c target value of ≤6.5%

    מסגרת זמן Baseline and week 76

  3. מדד תוצאה משני

    Change in body weight (absolute) from Baseline

    מסגרת זמן Baseline and week 76

  4. מדד תוצאה משני

    Percentage of participants who achieve ≥5% reduction in body weight

    מסגרת זמן Baseline and week 76

  5. מדד תוצאה משני

    Percentage of participants who achieve ≥10% reduction in body weight

    מסגרת זמן Baseline and week 76

  6. מדד תוצאה משני

    Percentage of participants who achieve ≥15% reduction in body weight

    מסגרת זמן Baseline and week 76

  7. מדד תוצאה משני

    Change in waist circumference from Baseline

    מסגרת זמן Baseline and week 76

  8. מדד תוצאה משני

    Change in HbA1c from Baseline

    מסגרת זמן Baseline and week 76

  9. מדד תוצאה משני

    Change in resting systolic blood pressure from Baseline

    מסגרת זמן Baseline and week 76

  10. מדד תוצאה משני

    Percent change in fasting triglycerides and non-HDL cholesterol from Baseline

    מסגרת זמן Baseline and week 76

תאריכים

תאריכים
תאריך התחלה17 ביולי 2026 (בפועל)
סיום ראשוני1 בספטמבר 2028 (משוער)
סיום1 בנובמבר 2028 (משוער)
פורסם לראשונה17 ביוני 2026 (בפועל)
עודכן לאחרונה11 בספטמבר 2026
התוצאות פורסמולא צוין ברשומת המרשם
המצב אומת לאחרונהיוני 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

43 אתרים מגייסים

United States

United States
מתקןעירמדינה או אזורמצב
ACCOMPLISH-2 Research SiteAlbanyNew Yorkטרם מגייס
ACCOMPLISH-2 Research SiteAlbanyNew Yorkטרם מגייס
ACCOMPLISH-2 Research SiteAtlantaGeorgiaמגייס
ACCOMPLISH-2 Research SiteAustinTexasמגייס
ACCOMPLISH-2 Research SiteBirminghamAlabamaמגייס
ACCOMPLISH-2 Research SiteBrooklynNew Yorkטרם מגייס
ACCOMPLISH-2 Research SiteBurkeVirginiaטרם מגייס
ACCOMPLISH-2 Research SiteChandlerArizonaמגייס
ACCOMPLISH-2 Research SiteCharlotteNorth Carolinaמגייס
ACCOMPLISH-2 Research SiteChesterfieldMissouriטרם מגייס
ACCOMPLISH-2 Research SiteCity of Saint PetersMissouriמגייס
ACCOMPLISH-2 Research SiteClearwaterFloridaמגייס
ACCOMPLISH-2 Research SiteColumbusGeorgiaטרם מגייס
ACCOMPLISH-2 Research SiteColumbusOhioמגייס
ACCOMPLISH-2 Research SiteDes MoinesIowaמגייס
ACCOMPLISH-2 Research SiteDurhamNorth Carolinaטרם מגייס
ACCOMPLISH-2 Research SiteEscondidoCaliforniaטרם מגייס
ACCOMPLISH-2 Research SiteFarmers BranchTexasטרם מגייס
ACCOMPLISH-2 Research SiteFayettevilleNorth Carolinaמגייס
ACCOMPLISH-2 Research SiteFort MyersFloridaמגייס
ACCOMPLISH-2 Research SiteFountain ValleyCaliforniaמגייס
ACCOMPLISH-2 Research SiteGreerSouth Carolinaמגייס
ACCOMPLISH-2 Research SiteGulfportMississippiמגייס
ACCOMPLISH-2 Research SiteHazelwoodMissouriמגייס
ACCOMPLISH-2 Research SiteHoustonTexasמגייס
ACCOMPLISH-2 Research SiteHoustonTexasמגייס
ACCOMPLISH-2 Research SiteIowa CityIowaטרם מגייס
ACCOMPLISH-2 Research SiteJacksonvilleFloridaטרם מגייס
ACCOMPLISH-2 Research SiteLa JollaCaliforniaמגייס
ACCOMPLISH-2 Research SiteLake ForestCaliforniaטרם מגייס
ACCOMPLISH-2 Research SiteLas VegasNevadaטרם מגייס
ACCOMPLISH-2 Research SiteLawrencevilleGeorgiaמגייס
ACCOMPLISH-2 Research SiteLeesburgFloridaמגייס
ACCOMPLISH-2 Research SiteLittle RockArkansasטרם מגייס
ACCOMPLISH-2 Research SiteManassasVirginiaמגייס
ACCOMPLISH-2 Research SiteMankatoMinnesotaמגייס
ACCOMPLISH-2 Research SiteMeridianIdahoמגייס
ACCOMPLISH-2 Research SiteMethuenMassachusettsמגייס
ACCOMPLISH-2 Research SiteMiamiFloridaטרם מגייס
ACCOMPLISH-2 Research SiteMinneapolisMinnesotaמגייס
ACCOMPLISH-2 Research SiteMissoulaMontanaמגייס
ACCOMPLISH-2 Research SiteMooreOklahomaמגייס
ACCOMPLISH-2 Research SiteMorehead CityNorth Carolinaטרם מגייס
ACCOMPLISH-2 Research SiteNashvilleTennesseeטרם מגייס
ACCOMPLISH-2 Research SiteOcalaFloridaמגייס
ACCOMPLISH-2 Research SiteOcoeeFloridaמגייס
ACCOMPLISH-2 Research SiteOmahaNebraskaטרם מגייס
ACCOMPLISH-2 Research SitePembroke PinesFloridaטרם מגייס
ACCOMPLISH-2 Research SitePhiladelphiaPennsylvaniaמגייס
ACCOMPLISH-2 Research SitePhoenixArizonaטרם מגייס

24 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

  1. 10 באוגוסט 2026

    המצב השתנה

    Status changed from Not yet recruiting to Recruiting

    NOT_YET_RECRUITINGRECRUITING

  2. 10 באוגוסט 2026

    הגיוס נפתח

    Recruitment opened

    NOT_YET_RECRUITINGRECRUITING