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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

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

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…

المرحلة 3مطلوب 3,600 مشارك71 موقعاًدولة واحدة

الفئات

الغدد الصمّاء والأيض83%القلب والأوعية الدموية17%

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

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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.

ملخص

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.

الحالات

  • Obesity
  • Overweight
  • Chronic Weight Management

الأهلية

الجنسالجميع
الأعمار18 Years – 79 Years
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

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

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةالمرحلة 3
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةTRIPLE (3)
التجنيدمطلوب 3,600 مشارك

الجهة الراعية والمتعاونون

  • Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics الجهة الراعية

الأذرع والتدخلات

  • 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.

التدخلات

  • دواء Aleniglipron

    Drug: aleniglipron administered orally Drug

  • دواء Placebo

    Drug: placebo administered orally

مقاييس النتائج

  1. مقياس النتيجة الأولي

    Percent change in body weight from Baseline

    الإطار الزمني Baseline and Week 76

  2. مقياس النتيجة الثانوي

    Change in body weight (absolute) from Baseline

    الإطار الزمني Baseline and week 76

  3. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline and week 76

  4. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline and week 76

  5. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline and week 76

  6. مقياس النتيجة الثانوي

    Percentage of participants who achieve ≥20% reduction in body weight

    الإطار الزمني Baseline and week 76

  7. مقياس النتيجة الثانوي

    Change in waist circumference from Baseline

    الإطار الزمني Baseline and week 76

  8. مقياس النتيجة الثانوي

    Change in resting systolic blood pressure from Baseline

    الإطار الزمني Baseline and week 76

  9. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline and week 76

  10. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline and week 76

  11. مقياس النتيجة الثانوي

    Change in HbA1c from Baseline

    الإطار الزمني Baseline and week 76

  12. مقياس النتيجة الثانوي

    Change in body mass index from Baseline

    الإطار الزمني Baseline and week 76

  13. مقياس النتيجة الثانوي

    Percent change in fasting total cholesterol from Baseline

    الإطار الزمني Baseline and week 76

  14. مقياس النتيجة الثانوي

    Change in fasting glucose from Baseline

    الإطار الزمني Baseline and week 76

  15. مقياس النتيجة الثانوي

    Change in resting diastolic blood pressure from Baseline

    الإطار الزمني Baseline and week 76

  16. مقياس نتيجة آخر

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

    الإطار الزمني Baseline and week 76

التواريخ

تاريخ البدء13 يوليو 2026 (فعلي)
الإتمام الأولي1 سبتمبر 2028 (تقديري)
الإتمام1 نوفمبر 2028 (تقديري)
أول نشر17 يونيو 2026 (فعلي)
آخر تحديث10 أغسطس 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةيونيو 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

13 موقعاً قيد التجنيد

United States

المنشأةالمدينةالولاية أو المنطقةالحالة
ACCOMPLISH-1 Research SiteAlbanyNew Yorkلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteAnn ArborMichiganلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteAustinTexasلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteAustinTexasقيد التجنيد
ACCOMPLISH-1 Research SiteBaton RougeLouisianaلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteBirminghamAlabamaلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteBirminghamAlabamaلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteBrooklynNew Yorkلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteBufordGeorgiaلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteButteMontanaلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteCharlotteNorth Carolinaقيد التجنيد
ACCOMPLISH-1 Research SiteChesterfieldMissouriلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteChicagoIllinoisلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteClearwaterFloridaقيد التجنيد
ACCOMPLISH-1 Research SiteColumbusOhioقيد التجنيد
ACCOMPLISH-1 Research SiteColumbusOhioلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteColumbusGeorgiaلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteDenisonTexasلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteDurhamNorth Carolinaلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteEscondidoCaliforniaلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteFayettevilleNorth Carolinaلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteGardenaCaliforniaلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteGreerSouth Carolinaلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteGulfportMississippiلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteHazelwoodMissouriقيد التجنيد
ACCOMPLISH-1 Research SiteHonoluluHawaiiقيد التجنيد
ACCOMPLISH-1 Research SiteHoustonTexasلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteHoustonTexasلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteIowa CityIowaلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteKnoxvilleTennesseeلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteLa JollaCaliforniaلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteLas VegasNevadaلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteLawrencevilleGeorgiaلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteLeesburgFloridaلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteLouisvilleKentuckyلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteMankatoMinnesotaقيد التجنيد
ACCOMPLISH-1 Research SiteMeridianIdahoلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteMethuenMassachusettsلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteMiamiFloridaلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteMissoulaMontanaلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteModestoCaliforniaلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteMooreOklahomaلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteNeedhamMassachusettsلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteNew BernNorth Carolinaلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteOcalaFloridaلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteOcoeeFloridaلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SiteOmahaNebraskaلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SitePembrokeFloridaلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SitePhiladelphiaPennsylvaniaلم يبدأ التجنيد بعد
ACCOMPLISH-1 Research SitePhoenixArizonaلم يبدأ التجنيد بعد

يُدرَج 21 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

  1. 10 أغسطس 2026

    تغيّرت الحالة

    Status changed from Not yet recruiting to Recruiting

    NOT_YET_RECRUITINGRECRUITING

  2. 10 أغسطس 2026

    فُتح التجنيد

    Recruitment opened

    NOT_YET_RECRUITINGRECRUITING

السجل: ClinicalTrials.gov · NCT########

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