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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

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

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…

Phase 33 600 participants recherchés71 sites1 pays

Catégories

Endocrinien et métabolique83%Cardiovasculaire17%

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Résumé

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.

Affections

  • Obesity
  • Overweight
  • Chronic Weight Management

Éligibilité

SexeTous
Âges18 Years – 79 Years
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeInterventionnelle
PhasePhase 3
RépartitionRandomisée
Modèle d'interventionPARALLEL
Objectif principalTREATMENT
InsuTRIPLE (3)
Recrutement3 600 participants recherchés

Promoteur et collaborateurs

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

Groupes et interventions

  • 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.

Interventions

  • Médicament Aleniglipron

    Drug: aleniglipron administered orally Drug

  • Médicament Placebo

    Drug: placebo administered orally

Critères de jugement

  1. Critère de jugement principal

    Percent change in body weight from Baseline

    Délai Baseline and Week 76

  2. Critère de jugement secondaire

    Change in body weight (absolute) from Baseline

    Délai Baseline and week 76

  3. Critère de jugement secondaire

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

    Délai Baseline and week 76

  4. Critère de jugement secondaire

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

    Délai Baseline and week 76

  5. Critère de jugement secondaire

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

    Délai Baseline and week 76

  6. Critère de jugement secondaire

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

    Délai Baseline and week 76

  7. Critère de jugement secondaire

    Change in waist circumference from Baseline

    Délai Baseline and week 76

  8. Critère de jugement secondaire

    Change in resting systolic blood pressure from Baseline

    Délai Baseline and week 76

  9. Critère de jugement secondaire

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

    Délai Baseline and week 76

  10. Critère de jugement secondaire

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

    Délai Baseline and week 76

  11. Critère de jugement secondaire

    Change in HbA1c from Baseline

    Délai Baseline and week 76

  12. Critère de jugement secondaire

    Change in body mass index from Baseline

    Délai Baseline and week 76

  13. Critère de jugement secondaire

    Percent change in fasting total cholesterol from Baseline

    Délai Baseline and week 76

  14. Critère de jugement secondaire

    Change in fasting glucose from Baseline

    Délai Baseline and week 76

  15. Critère de jugement secondaire

    Change in resting diastolic blood pressure from Baseline

    Délai Baseline and week 76

  16. Autre critère de jugement

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

    Délai Baseline and week 76

Dates

Date de début13 juillet 2026 (réelle)
Achèvement principal1 septembre 2028 (estimée)
Achèvement1 novembre 2028 (estimée)
Première publication17 juin 2026 (réelle)
Dernière mise à jour10 août 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisjuin 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

13 sites sont en recrutement

United States

ÉtablissementVilleÉtat ou régionStatut
ACCOMPLISH-1 Research SiteAlbanyNew YorkPas encore en recrutement
ACCOMPLISH-1 Research SiteAnn ArborMichiganPas encore en recrutement
ACCOMPLISH-1 Research SiteAustinTexasPas encore en recrutement
ACCOMPLISH-1 Research SiteAustinTexasEn recrutement
ACCOMPLISH-1 Research SiteBaton RougeLouisianaPas encore en recrutement
ACCOMPLISH-1 Research SiteBirminghamAlabamaPas encore en recrutement
ACCOMPLISH-1 Research SiteBirminghamAlabamaPas encore en recrutement
ACCOMPLISH-1 Research SiteBrooklynNew YorkPas encore en recrutement
ACCOMPLISH-1 Research SiteBufordGeorgiaPas encore en recrutement
ACCOMPLISH-1 Research SiteButteMontanaPas encore en recrutement
ACCOMPLISH-1 Research SiteCharlotteNorth CarolinaEn recrutement
ACCOMPLISH-1 Research SiteChesterfieldMissouriPas encore en recrutement
ACCOMPLISH-1 Research SiteChicagoIllinoisPas encore en recrutement
ACCOMPLISH-1 Research SiteClearwaterFloridaEn recrutement
ACCOMPLISH-1 Research SiteColumbusOhioEn recrutement
ACCOMPLISH-1 Research SiteColumbusOhioPas encore en recrutement
ACCOMPLISH-1 Research SiteColumbusGeorgiaPas encore en recrutement
ACCOMPLISH-1 Research SiteDenisonTexasPas encore en recrutement
ACCOMPLISH-1 Research SiteDurhamNorth CarolinaPas encore en recrutement
ACCOMPLISH-1 Research SiteEscondidoCaliforniaPas encore en recrutement
ACCOMPLISH-1 Research SiteFayettevilleNorth CarolinaPas encore en recrutement
ACCOMPLISH-1 Research SiteGardenaCaliforniaPas encore en recrutement
ACCOMPLISH-1 Research SiteGreerSouth CarolinaPas encore en recrutement
ACCOMPLISH-1 Research SiteGulfportMississippiPas encore en recrutement
ACCOMPLISH-1 Research SiteHazelwoodMissouriEn recrutement
ACCOMPLISH-1 Research SiteHonoluluHawaiiEn recrutement
ACCOMPLISH-1 Research SiteHoustonTexasPas encore en recrutement
ACCOMPLISH-1 Research SiteHoustonTexasPas encore en recrutement
ACCOMPLISH-1 Research SiteIowa CityIowaPas encore en recrutement
ACCOMPLISH-1 Research SiteKnoxvilleTennesseePas encore en recrutement
ACCOMPLISH-1 Research SiteLa JollaCaliforniaPas encore en recrutement
ACCOMPLISH-1 Research SiteLas VegasNevadaPas encore en recrutement
ACCOMPLISH-1 Research SiteLawrencevilleGeorgiaPas encore en recrutement
ACCOMPLISH-1 Research SiteLeesburgFloridaPas encore en recrutement
ACCOMPLISH-1 Research SiteLouisvilleKentuckyPas encore en recrutement
ACCOMPLISH-1 Research SiteMankatoMinnesotaEn recrutement
ACCOMPLISH-1 Research SiteMeridianIdahoPas encore en recrutement
ACCOMPLISH-1 Research SiteMethuenMassachusettsPas encore en recrutement
ACCOMPLISH-1 Research SiteMiamiFloridaPas encore en recrutement
ACCOMPLISH-1 Research SiteMissoulaMontanaPas encore en recrutement
ACCOMPLISH-1 Research SiteModestoCaliforniaPas encore en recrutement
ACCOMPLISH-1 Research SiteMooreOklahomaPas encore en recrutement
ACCOMPLISH-1 Research SiteNeedhamMassachusettsPas encore en recrutement
ACCOMPLISH-1 Research SiteNew BernNorth CarolinaPas encore en recrutement
ACCOMPLISH-1 Research SiteOcalaFloridaPas encore en recrutement
ACCOMPLISH-1 Research SiteOcoeeFloridaPas encore en recrutement
ACCOMPLISH-1 Research SiteOmahaNebraskaPas encore en recrutement
ACCOMPLISH-1 Research SitePembrokeFloridaPas encore en recrutement
ACCOMPLISH-1 Research SitePhiladelphiaPennsylvaniaPas encore en recrutement
ACCOMPLISH-1 Research SitePhoenixArizonaPas encore en recrutement

21 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

  1. 10 août 2026

    Statut modifié

    Status changed from Not yet recruiting to Recruiting

    NOT_YET_RECRUITINGRECRUITING

  2. 10 août 2026

    Recrutement ouvert

    Recruitment opened

    NOT_YET_RECRUITINGRECRUITING

Registre: ClinicalTrials.gov · NCT########

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