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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

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En resumen

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…

Fase 33600 participantes buscados71 centros1 país

Categorías

Endocrino y metabólico83%Cardiovascular17%

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.

  • 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.

Resumen

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.

Afecciones

  • Obesity
  • Overweight
  • Chronic Weight Management

Elegibilidad

SexoTodos
Edades18 Years – 79 Years
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

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

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

Tipo de estudioDe intervención
FaseFase 3
AsignaciónAleatorizado
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoTRIPLE (3)
Inscripción3600 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 4EXPERIMENTAL

    Participants will receive placebo administered orally.

Intervenciones

  • Fármaco Aleniglipron

    Drug: aleniglipron administered orally Drug

  • Fármaco Placebo

    Drug: placebo 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

    Change in body weight (absolute) from Baseline

    Plazo Baseline and week 76

  3. Variable de resultado secundaria

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

    Plazo Baseline and week 76

  4. Variable de resultado secundaria

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

    Plazo Baseline and week 76

  5. Variable de resultado secundaria

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

    Plazo Baseline and week 76

  6. Variable de resultado secundaria

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

    Plazo Baseline and week 76

  9. Variable de resultado secundaria

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

    Plazo Baseline and week 76

  10. Variable de resultado secundaria

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

    Plazo Baseline and week 76

  11. Variable de resultado secundaria

    Change in HbA1c from Baseline

    Plazo Baseline and week 76

  12. Variable de resultado secundaria

    Change in body mass index from Baseline

    Plazo Baseline and week 76

  13. Variable de resultado secundaria

    Percent change in fasting total cholesterol from Baseline

    Plazo Baseline and week 76

  14. Variable de resultado secundaria

    Change in fasting glucose from Baseline

    Plazo Baseline and week 76

  15. Variable de resultado secundaria

    Change in resting diastolic blood pressure from Baseline

    Plazo Baseline and week 76

  16. Otra variable de resultado

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

    Plazo Baseline and week 76

Fechas

Fecha de inicio13 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 actualización10 de agosto 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

13 centros están en reclutamiento

United States

CentroCiudadEstado o regiónEstado
ACCOMPLISH-1 Research SiteAlbanyNew YorkAún no recluta
ACCOMPLISH-1 Research SiteAnn ArborMichiganAún no recluta
ACCOMPLISH-1 Research SiteAustinTexasAún no recluta
ACCOMPLISH-1 Research SiteAustinTexasEn reclutamiento
ACCOMPLISH-1 Research SiteBaton RougeLouisianaAún no recluta
ACCOMPLISH-1 Research SiteBirminghamAlabamaAún no recluta
ACCOMPLISH-1 Research SiteBirminghamAlabamaAún no recluta
ACCOMPLISH-1 Research SiteBrooklynNew YorkAún no recluta
ACCOMPLISH-1 Research SiteBufordGeorgiaAún no recluta
ACCOMPLISH-1 Research SiteButteMontanaAún no recluta
ACCOMPLISH-1 Research SiteCharlotteNorth CarolinaEn reclutamiento
ACCOMPLISH-1 Research SiteChesterfieldMissouriAún no recluta
ACCOMPLISH-1 Research SiteChicagoIllinoisAún no recluta
ACCOMPLISH-1 Research SiteClearwaterFloridaEn reclutamiento
ACCOMPLISH-1 Research SiteColumbusOhioEn reclutamiento
ACCOMPLISH-1 Research SiteColumbusOhioAún no recluta
ACCOMPLISH-1 Research SiteColumbusGeorgiaAún no recluta
ACCOMPLISH-1 Research SiteDenisonTexasAún no recluta
ACCOMPLISH-1 Research SiteDurhamNorth CarolinaAún no recluta
ACCOMPLISH-1 Research SiteEscondidoCaliforniaAún no recluta
ACCOMPLISH-1 Research SiteFayettevilleNorth CarolinaAún no recluta
ACCOMPLISH-1 Research SiteGardenaCaliforniaAún no recluta
ACCOMPLISH-1 Research SiteGreerSouth CarolinaAún no recluta
ACCOMPLISH-1 Research SiteGulfportMississippiAún no recluta
ACCOMPLISH-1 Research SiteHazelwoodMissouriEn reclutamiento
ACCOMPLISH-1 Research SiteHonoluluHawaiiEn reclutamiento
ACCOMPLISH-1 Research SiteHoustonTexasAún no recluta
ACCOMPLISH-1 Research SiteHoustonTexasAún no recluta
ACCOMPLISH-1 Research SiteIowa CityIowaAún no recluta
ACCOMPLISH-1 Research SiteKnoxvilleTennesseeAún no recluta
ACCOMPLISH-1 Research SiteLa JollaCaliforniaAún no recluta
ACCOMPLISH-1 Research SiteLas VegasNevadaAún no recluta
ACCOMPLISH-1 Research SiteLawrencevilleGeorgiaAún no recluta
ACCOMPLISH-1 Research SiteLeesburgFloridaAún no recluta
ACCOMPLISH-1 Research SiteLouisvilleKentuckyAún no recluta
ACCOMPLISH-1 Research SiteMankatoMinnesotaEn reclutamiento
ACCOMPLISH-1 Research SiteMeridianIdahoAún no recluta
ACCOMPLISH-1 Research SiteMethuenMassachusettsAún no recluta
ACCOMPLISH-1 Research SiteMiamiFloridaAún no recluta
ACCOMPLISH-1 Research SiteMissoulaMontanaAún no recluta
ACCOMPLISH-1 Research SiteModestoCaliforniaAún no recluta
ACCOMPLISH-1 Research SiteMooreOklahomaAún no recluta
ACCOMPLISH-1 Research SiteNeedhamMassachusettsAún no recluta
ACCOMPLISH-1 Research SiteNew BernNorth CarolinaAún no recluta
ACCOMPLISH-1 Research SiteOcalaFloridaAún no recluta
ACCOMPLISH-1 Research SiteOcoeeFloridaAún no recluta
ACCOMPLISH-1 Research SiteOmahaNebraskaAún no recluta
ACCOMPLISH-1 Research SitePembrokeFloridaAún no recluta
ACCOMPLISH-1 Research SitePhiladelphiaPennsylvaniaAún no recluta
ACCOMPLISH-1 Research SitePhoenixArizonaAún no recluta

En el registro figuran 21 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

Registro: ClinicalTrials.gov · NCT########

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