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NCT07654361ClinicalTrials.gov

Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1)

A Randomized, Double-Blind, Placebo-Controlled, Pivotal Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of Multiple Maintenance Doses of Once Daily Oral Aleniglipron for Chronic Weight Management in Adults With Obesity or Overweight and a Weight-Related Comorbidity

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

בקצרה

Study GSBR-1290-12 is a Phase 3 pivotal, multicenter, global, randomized, placebo-controlled, double-blind study to investigate the long-term efficacy, safety, and tolerability of 3 maintenance doses of aleniglipron once daily (QD) compared with placebo, when used in combination with a reduced-calorie…

שלב 3דרושים 3,600 משתתפים71 אתריםמדינה אחת

קטגוריות

אנדוקריני ומטבולי83%לב וכלי דם17%

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.

  • Registered before enrolment beganFirst posted 2026-06-17; recorded start 2026-07-13
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • 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.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • 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)
  • No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
  • The record lists 3 conditions.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

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 rigourSTRONG

A strong methodological 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 arm0/15

    No comparator arm stated in the record

  • 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: 71 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: 3,600 participants (target), run at 71 sites.

How this score is built
  • Enrolment35/40

    3,600 participants (target)

  • Site count21/25

    71 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

Study GSBR-1290-12 is a Phase 3 pivotal, multicenter, global, randomized, placebo-controlled, double-blind study to investigate the long-term efficacy, safety, and tolerability of 3 maintenance doses of aleniglipron once daily (QD) compared with placebo, when used in combination with a reduced-calorie diet and increased physical activity. All participants will be randomized to at least 76 weeks of treatment to evaluate the effects on long term body weight changes, tolerability, and safety. In addition, the study will compare the effects between aleniglipron and placebo on blood pressure (BP), lipid parameters, patient-reported outcomes.

מצבים רפואיים

  • Obesity
  • Overweight
  • Chronic Weight Management

זכאות

מיןהכול
גילאים18 Years – 79 Years
מתנדבים בריאיםלא

זכאות כפי שנכתבה במרשם

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 change in body weight \>5 kg within 3 months before Screening. * Have prior or planned surgical or non-surgical treatment for obesity. * Have or plan to have endoscopic and/or device-based therapy for obesity. * Have obesity induced by other endocrine disorders. * Impaired renal function at Screening * Chronic malabsorption

זכאות במשפטים פשוטים

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

תכנון המחקר

סוג המחקרהתערבותי
שלבשלב 3
הקצאהאקראי
מודל ההתערבותPARALLEL
מטרה ראשיתTREATMENT
הסתרהTRIPLE (3)
גיוסדרושים 3,600 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 4EXPERIMENTAL

    Participants will receive placebo administered orally.

התערבויות

  • תרופה Aleniglipron

    Drug: aleniglipron administered orally Drug

  • תרופה Placebo

    Drug: placebo 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

    Change in body weight (absolute) from Baseline

    מסגרת זמן Baseline and week 76

  3. מדד תוצאה משני

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

    מסגרת זמן Baseline and week 76

  4. מדד תוצאה משני

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

    מסגרת זמן Baseline and week 76

  5. מדד תוצאה משני

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

    מסגרת זמן Baseline and week 76

  6. מדד תוצאה משני

    Percentage of participants who achieve ≥20% 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 resting systolic blood pressure from Baseline

    מסגרת זמן Baseline and week 76

  9. מדד תוצאה משני

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

    מסגרת זמן Baseline and week 76

  10. מדד תוצאה משני

    Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version physical function from Baseline

    מסגרת זמן Baseline and week 76

  11. מדד תוצאה משני

    Change in HbA1c from Baseline

    מסגרת זמן Baseline and week 76

  12. מדד תוצאה משני

    Change in body mass index from Baseline

    מסגרת זמן Baseline and week 76

  13. מדד תוצאה משני

    Percent change in fasting total cholesterol from Baseline

    מסגרת זמן Baseline and week 76

  14. מדד תוצאה משני

    Change in fasting glucose from Baseline

    מסגרת זמן Baseline and week 76

  15. מדד תוצאה משני

    Change in resting diastolic blood pressure from Baseline

    מסגרת זמן Baseline and week 76

  16. מדד תוצאה אחר

    Percentage of participants who achieve ≥25% reduction in body weight

    מסגרת זמן Baseline and week 76

תאריכים

תאריך התחלה13 ביולי 2026 (בפועל)
סיום ראשוני1 בספטמבר 2028 (משוער)
סיום1 בנובמבר 2028 (משוער)
פורסם לראשונה17 ביוני 2026 (בפועל)
עודכן לאחרונה10 באוגוסט 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

13 אתרים מגייסים

United States

מתקןעירמדינה או אזורמצב
ACCOMPLISH-1 Research SiteAlbanyNew Yorkטרם מגייס
ACCOMPLISH-1 Research SiteAnn ArborMichiganטרם מגייס
ACCOMPLISH-1 Research SiteAustinTexasטרם מגייס
ACCOMPLISH-1 Research SiteAustinTexasמגייס
ACCOMPLISH-1 Research SiteBaton RougeLouisianaטרם מגייס
ACCOMPLISH-1 Research SiteBirminghamAlabamaטרם מגייס
ACCOMPLISH-1 Research SiteBirminghamAlabamaטרם מגייס
ACCOMPLISH-1 Research SiteBrooklynNew Yorkטרם מגייס
ACCOMPLISH-1 Research SiteBufordGeorgiaטרם מגייס
ACCOMPLISH-1 Research SiteButteMontanaטרם מגייס
ACCOMPLISH-1 Research SiteCharlotteNorth Carolinaמגייס
ACCOMPLISH-1 Research SiteChesterfieldMissouriטרם מגייס
ACCOMPLISH-1 Research SiteChicagoIllinoisטרם מגייס
ACCOMPLISH-1 Research SiteClearwaterFloridaמגייס
ACCOMPLISH-1 Research SiteColumbusOhioמגייס
ACCOMPLISH-1 Research SiteColumbusOhioטרם מגייס
ACCOMPLISH-1 Research SiteColumbusGeorgiaטרם מגייס
ACCOMPLISH-1 Research SiteDenisonTexasטרם מגייס
ACCOMPLISH-1 Research SiteDurhamNorth Carolinaטרם מגייס
ACCOMPLISH-1 Research SiteEscondidoCaliforniaטרם מגייס
ACCOMPLISH-1 Research SiteFayettevilleNorth Carolinaטרם מגייס
ACCOMPLISH-1 Research SiteGardenaCaliforniaטרם מגייס
ACCOMPLISH-1 Research SiteGreerSouth Carolinaטרם מגייס
ACCOMPLISH-1 Research SiteGulfportMississippiטרם מגייס
ACCOMPLISH-1 Research SiteHazelwoodMissouriמגייס
ACCOMPLISH-1 Research SiteHonoluluHawaiiמגייס
ACCOMPLISH-1 Research SiteHoustonTexasטרם מגייס
ACCOMPLISH-1 Research SiteHoustonTexasטרם מגייס
ACCOMPLISH-1 Research SiteIowa CityIowaטרם מגייס
ACCOMPLISH-1 Research SiteKnoxvilleTennesseeטרם מגייס
ACCOMPLISH-1 Research SiteLa JollaCaliforniaטרם מגייס
ACCOMPLISH-1 Research SiteLas VegasNevadaטרם מגייס
ACCOMPLISH-1 Research SiteLawrencevilleGeorgiaטרם מגייס
ACCOMPLISH-1 Research SiteLeesburgFloridaטרם מגייס
ACCOMPLISH-1 Research SiteLouisvilleKentuckyטרם מגייס
ACCOMPLISH-1 Research SiteMankatoMinnesotaמגייס
ACCOMPLISH-1 Research SiteMeridianIdahoטרם מגייס
ACCOMPLISH-1 Research SiteMethuenMassachusettsטרם מגייס
ACCOMPLISH-1 Research SiteMiamiFloridaטרם מגייס
ACCOMPLISH-1 Research SiteMissoulaMontanaטרם מגייס
ACCOMPLISH-1 Research SiteModestoCaliforniaטרם מגייס
ACCOMPLISH-1 Research SiteMooreOklahomaטרם מגייס
ACCOMPLISH-1 Research SiteNeedhamMassachusettsטרם מגייס
ACCOMPLISH-1 Research SiteNew BernNorth Carolinaטרם מגייס
ACCOMPLISH-1 Research SiteOcalaFloridaטרם מגייס
ACCOMPLISH-1 Research SiteOcoeeFloridaטרם מגייס
ACCOMPLISH-1 Research SiteOmahaNebraskaטרם מגייס
ACCOMPLISH-1 Research SitePembrokeFloridaטרם מגייס
ACCOMPLISH-1 Research SitePhiladelphiaPennsylvaniaטרם מגייס
ACCOMPLISH-1 Research SitePhoenixArizonaטרם מגייס

21 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

מרשם: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07654361