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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)

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

باختصار

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…

المرحلة 3مطلوب 1,100 مشارك74 موقعاًدولة واحدة

الفئات

مسجَّلة في سجل واحد

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

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

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.

ملخص

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.

الحالات

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

الأهلية

الأهلية
الجنسالجميع
الأعمار18 Years79 Years
المتطوعون الأصحّاءنعم

الأهلية كما كُتبت في السجل

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.

الأهلية في عبارات بسيطة

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

تصميم الدراسة

تصميم الدراسة
نوع الدراسةتدخّلية
المرحلةالمرحلة 3
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةTRIPLE (3)
التجنيدمطلوب 1,100 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 4PLACEBO_COMPARATOR

    Participants will receive placebo administered orally.

التدخلات

  • دواء Placebo

    Drug: placebo administered orally

  • دواء aleniglipron

    Drug: aleniglipron administered orally

  • دواء aleniglipron

    Drug: aleniglipron administered orally

  • دواء aleniglipron

    Drug: aleniglipron 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

    Percentage of participants achieving HbA1c target value of ≤6.5%

    الإطار الزمني Baseline and week 76

  3. مقياس النتيجة الثانوي

    Change in body weight (absolute) from Baseline

    الإطار الزمني Baseline and week 76

  4. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline and week 76

  5. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline and week 76

  6. مقياس النتيجة الثانوي

    Percentage of participants who achieve ≥15% 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 HbA1c from Baseline

    الإطار الزمني Baseline and week 76

  9. مقياس النتيجة الثانوي

    Change in resting systolic blood pressure from Baseline

    الإطار الزمني Baseline and week 76

  10. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline and week 76

التواريخ

التواريخ
تاريخ البدء17 يوليو 2026 (فعلي)
الإتمام الأولي1 سبتمبر 2028 (تقديري)
الإتمام1 نوفمبر 2028 (تقديري)
أول نشر17 يونيو 2026 (فعلي)
آخر تحديث11 سبتمبر 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

43 موقعاً قيد التجنيد

United States

United States
المنشأةالمدينةالولاية أو المنطقةالحالة
ACCOMPLISH-2 Research SiteAlbanyNew Yorkلم يبدأ التجنيد بعد
ACCOMPLISH-2 Research SiteAlbanyNew Yorkلم يبدأ التجنيد بعد
ACCOMPLISH-2 Research SiteAtlantaGeorgiaقيد التجنيد
ACCOMPLISH-2 Research SiteAustinTexasقيد التجنيد
ACCOMPLISH-2 Research SiteBirminghamAlabamaقيد التجنيد
ACCOMPLISH-2 Research SiteBrooklynNew Yorkلم يبدأ التجنيد بعد
ACCOMPLISH-2 Research SiteBurkeVirginiaلم يبدأ التجنيد بعد
ACCOMPLISH-2 Research SiteChandlerArizonaقيد التجنيد
ACCOMPLISH-2 Research SiteCharlotteNorth Carolinaقيد التجنيد
ACCOMPLISH-2 Research SiteChesterfieldMissouriلم يبدأ التجنيد بعد
ACCOMPLISH-2 Research SiteCity of Saint PetersMissouriقيد التجنيد
ACCOMPLISH-2 Research SiteClearwaterFloridaقيد التجنيد
ACCOMPLISH-2 Research SiteColumbusGeorgiaلم يبدأ التجنيد بعد
ACCOMPLISH-2 Research SiteColumbusOhioقيد التجنيد
ACCOMPLISH-2 Research SiteDes MoinesIowaقيد التجنيد
ACCOMPLISH-2 Research SiteDurhamNorth Carolinaلم يبدأ التجنيد بعد
ACCOMPLISH-2 Research SiteEscondidoCaliforniaلم يبدأ التجنيد بعد
ACCOMPLISH-2 Research SiteFarmers BranchTexasلم يبدأ التجنيد بعد
ACCOMPLISH-2 Research SiteFayettevilleNorth Carolinaقيد التجنيد
ACCOMPLISH-2 Research SiteFort MyersFloridaقيد التجنيد
ACCOMPLISH-2 Research SiteFountain ValleyCaliforniaقيد التجنيد
ACCOMPLISH-2 Research SiteGreerSouth Carolinaقيد التجنيد
ACCOMPLISH-2 Research SiteGulfportMississippiقيد التجنيد
ACCOMPLISH-2 Research SiteHazelwoodMissouriقيد التجنيد
ACCOMPLISH-2 Research SiteHoustonTexasقيد التجنيد
ACCOMPLISH-2 Research SiteHoustonTexasقيد التجنيد
ACCOMPLISH-2 Research SiteIowa CityIowaلم يبدأ التجنيد بعد
ACCOMPLISH-2 Research SiteJacksonvilleFloridaلم يبدأ التجنيد بعد
ACCOMPLISH-2 Research SiteLa JollaCaliforniaقيد التجنيد
ACCOMPLISH-2 Research SiteLake ForestCaliforniaلم يبدأ التجنيد بعد
ACCOMPLISH-2 Research SiteLas VegasNevadaلم يبدأ التجنيد بعد
ACCOMPLISH-2 Research SiteLawrencevilleGeorgiaقيد التجنيد
ACCOMPLISH-2 Research SiteLeesburgFloridaقيد التجنيد
ACCOMPLISH-2 Research SiteLittle RockArkansasلم يبدأ التجنيد بعد
ACCOMPLISH-2 Research SiteManassasVirginiaقيد التجنيد
ACCOMPLISH-2 Research SiteMankatoMinnesotaقيد التجنيد
ACCOMPLISH-2 Research SiteMeridianIdahoقيد التجنيد
ACCOMPLISH-2 Research SiteMethuenMassachusettsقيد التجنيد
ACCOMPLISH-2 Research SiteMiamiFloridaلم يبدأ التجنيد بعد
ACCOMPLISH-2 Research SiteMinneapolisMinnesotaقيد التجنيد
ACCOMPLISH-2 Research SiteMissoulaMontanaقيد التجنيد
ACCOMPLISH-2 Research SiteMooreOklahomaقيد التجنيد
ACCOMPLISH-2 Research SiteMorehead CityNorth Carolinaلم يبدأ التجنيد بعد
ACCOMPLISH-2 Research SiteNashvilleTennesseeلم يبدأ التجنيد بعد
ACCOMPLISH-2 Research SiteOcalaFloridaقيد التجنيد
ACCOMPLISH-2 Research SiteOcoeeFloridaقيد التجنيد
ACCOMPLISH-2 Research SiteOmahaNebraskaلم يبدأ التجنيد بعد
ACCOMPLISH-2 Research SitePembroke PinesFloridaلم يبدأ التجنيد بعد
ACCOMPLISH-2 Research SitePhiladelphiaPennsylvaniaقيد التجنيد
ACCOMPLISH-2 Research SitePhoenixArizonaلم يبدأ التجنيد بعد

يُدرَج 24 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