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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)

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En resumen

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…

Fase 31100 participantes buscados74 centros1 país

Categorías

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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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.

  • 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.

Resumen

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.

Afecciones

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

Elegibilidad

Elegibilidad
SexoTodos
Edades18 Years79 Years
Voluntarios sanos

Elegibilidad tal como figura en el registro

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.

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Diseño del estudio
Tipo de estudioDe intervención
FaseFase 3
AsignaciónAleatorizado
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoTRIPLE (3)
Inscripción1100 participantes buscados

Patrocinador y colaboradores

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

Grupos e intervenciones

  • 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.

Intervenciones

  • Fármaco Placebo

    Drug: placebo administered orally

  • Fármaco aleniglipron

    Drug: aleniglipron administered orally

  • Fármaco aleniglipron

    Drug: aleniglipron administered orally

  • Fármaco aleniglipron

    Drug: aleniglipron administered orally

Variables de resultado

  1. Variable de resultado principal

    Percent change in body weight from Baseline

    Plazo Baseline and week 76

  2. Variable de resultado secundaria

    Percentage of participants achieving HbA1c target value of ≤6.5%

    Plazo Baseline and week 76

  3. Variable de resultado secundaria

    Change in body weight (absolute) from Baseline

    Plazo Baseline and week 76

  4. Variable de resultado secundaria

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

    Plazo Baseline and week 76

  5. Variable de resultado secundaria

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

    Plazo Baseline and week 76

  6. Variable de resultado secundaria

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

    Plazo Baseline and week 76

  7. Variable de resultado secundaria

    Change in waist circumference from Baseline

    Plazo Baseline and week 76

  8. Variable de resultado secundaria

    Change in HbA1c from Baseline

    Plazo Baseline and week 76

  9. Variable de resultado secundaria

    Change in resting systolic blood pressure from Baseline

    Plazo Baseline and week 76

  10. Variable de resultado secundaria

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

    Plazo Baseline and week 76

Fechas

Fechas
Fecha de inicio17 de julio de 2026 (real)
Finalización principal1 de septiembre de 2028 (estimada)
Finalización1 de noviembre de 2028 (estimada)
Primera publicación17 de junio de 2026 (real)
Última actualización11 de septiembre de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezjunio de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

43 centros están en reclutamiento

United States

United States
CentroCiudadEstado o regiónEstado
ACCOMPLISH-2 Research SiteAlbanyNew YorkAún no recluta
ACCOMPLISH-2 Research SiteAlbanyNew YorkAún no recluta
ACCOMPLISH-2 Research SiteAtlantaGeorgiaEn reclutamiento
ACCOMPLISH-2 Research SiteAustinTexasEn reclutamiento
ACCOMPLISH-2 Research SiteBirminghamAlabamaEn reclutamiento
ACCOMPLISH-2 Research SiteBrooklynNew YorkAún no recluta
ACCOMPLISH-2 Research SiteBurkeVirginiaAún no recluta
ACCOMPLISH-2 Research SiteChandlerArizonaEn reclutamiento
ACCOMPLISH-2 Research SiteCharlotteNorth CarolinaEn reclutamiento
ACCOMPLISH-2 Research SiteChesterfieldMissouriAún no recluta
ACCOMPLISH-2 Research SiteCity of Saint PetersMissouriEn reclutamiento
ACCOMPLISH-2 Research SiteClearwaterFloridaEn reclutamiento
ACCOMPLISH-2 Research SiteColumbusGeorgiaAún no recluta
ACCOMPLISH-2 Research SiteColumbusOhioEn reclutamiento
ACCOMPLISH-2 Research SiteDes MoinesIowaEn reclutamiento
ACCOMPLISH-2 Research SiteDurhamNorth CarolinaAún no recluta
ACCOMPLISH-2 Research SiteEscondidoCaliforniaAún no recluta
ACCOMPLISH-2 Research SiteFarmers BranchTexasAún no recluta
ACCOMPLISH-2 Research SiteFayettevilleNorth CarolinaEn reclutamiento
ACCOMPLISH-2 Research SiteFort MyersFloridaEn reclutamiento
ACCOMPLISH-2 Research SiteFountain ValleyCaliforniaEn reclutamiento
ACCOMPLISH-2 Research SiteGreerSouth CarolinaEn reclutamiento
ACCOMPLISH-2 Research SiteGulfportMississippiEn reclutamiento
ACCOMPLISH-2 Research SiteHazelwoodMissouriEn reclutamiento
ACCOMPLISH-2 Research SiteHoustonTexasEn reclutamiento
ACCOMPLISH-2 Research SiteHoustonTexasEn reclutamiento
ACCOMPLISH-2 Research SiteIowa CityIowaAún no recluta
ACCOMPLISH-2 Research SiteJacksonvilleFloridaAún no recluta
ACCOMPLISH-2 Research SiteLa JollaCaliforniaEn reclutamiento
ACCOMPLISH-2 Research SiteLake ForestCaliforniaAún no recluta
ACCOMPLISH-2 Research SiteLas VegasNevadaAún no recluta
ACCOMPLISH-2 Research SiteLawrencevilleGeorgiaEn reclutamiento
ACCOMPLISH-2 Research SiteLeesburgFloridaEn reclutamiento
ACCOMPLISH-2 Research SiteLittle RockArkansasAún no recluta
ACCOMPLISH-2 Research SiteManassasVirginiaEn reclutamiento
ACCOMPLISH-2 Research SiteMankatoMinnesotaEn reclutamiento
ACCOMPLISH-2 Research SiteMeridianIdahoEn reclutamiento
ACCOMPLISH-2 Research SiteMethuenMassachusettsEn reclutamiento
ACCOMPLISH-2 Research SiteMiamiFloridaAún no recluta
ACCOMPLISH-2 Research SiteMinneapolisMinnesotaEn reclutamiento
ACCOMPLISH-2 Research SiteMissoulaMontanaEn reclutamiento
ACCOMPLISH-2 Research SiteMooreOklahomaEn reclutamiento
ACCOMPLISH-2 Research SiteMorehead CityNorth CarolinaAún no recluta
ACCOMPLISH-2 Research SiteNashvilleTennesseeAún no recluta
ACCOMPLISH-2 Research SiteOcalaFloridaEn reclutamiento
ACCOMPLISH-2 Research SiteOcoeeFloridaEn reclutamiento
ACCOMPLISH-2 Research SiteOmahaNebraskaAún no recluta
ACCOMPLISH-2 Research SitePembroke PinesFloridaAún no recluta
ACCOMPLISH-2 Research SitePhiladelphiaPennsylvaniaEn reclutamiento
ACCOMPLISH-2 Research SitePhoenixArizonaAún no recluta

En el registro figuran 24 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

  1. 10 de agosto de 2026

    Estado modificado

    Status changed from Not yet recruiting to Recruiting

    NOT_YET_RECRUITINGRECRUITING

  2. 10 de agosto de 2026

    Reclutamiento abierto

    Recruitment opened

    NOT_YET_RECRUITINGRECRUITING