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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)

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

En bref

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…

Phase 31 100 participants recherchés74 sites1 pays

Catégories

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.

  • 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.

Résumé

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.

Affections

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

Éligibilité

Éligibilité
SexeTous
Âges18 Years79 Years
Volontaires sainsOui

Éligibilité telle qu'elle figure dans le registre

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.

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

Conception de l'étude
Type d'étudeInterventionnelle
PhasePhase 3
RépartitionRandomisée
Modèle d'interventionPARALLEL
Objectif principalTREATMENT
InsuTRIPLE (3)
Recrutement1 100 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 4PLACEBO_COMPARATOR

    Participants will receive placebo administered orally.

Interventions

  • Médicament Placebo

    Drug: placebo administered orally

  • Médicament aleniglipron

    Drug: aleniglipron administered orally

  • Médicament aleniglipron

    Drug: aleniglipron administered orally

  • Médicament aleniglipron

    Drug: aleniglipron 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

    Percentage of participants achieving HbA1c target value of ≤6.5%

    Délai Baseline and week 76

  3. Critère de jugement secondaire

    Change in body weight (absolute) from Baseline

    Délai Baseline and week 76

  4. Critère de jugement secondaire

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

    Délai Baseline and week 76

  5. Critère de jugement secondaire

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

    Délai Baseline and week 76

  6. Critère de jugement secondaire

    Percentage of participants who achieve ≥15% 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 HbA1c from Baseline

    Délai Baseline and week 76

  9. Critère de jugement secondaire

    Change in resting systolic blood pressure from Baseline

    Délai Baseline and week 76

  10. Critère de jugement secondaire

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

    Délai Baseline and week 76

Dates

Dates
Date de début17 juillet 2026 (réelle)
Achèvement principal1 septembre 2028 (estimée)
Achèvement1 novembre 2028 (estimée)
Première publication17 juin 2026 (réelle)
Dernière mise à jour11 septembre 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

43 sites sont en recrutement

United States

United States
ÉtablissementVilleÉtat ou régionStatut
ACCOMPLISH-2 Research SiteAlbanyNew YorkPas encore en recrutement
ACCOMPLISH-2 Research SiteAlbanyNew YorkPas encore en recrutement
ACCOMPLISH-2 Research SiteAtlantaGeorgiaEn recrutement
ACCOMPLISH-2 Research SiteAustinTexasEn recrutement
ACCOMPLISH-2 Research SiteBirminghamAlabamaEn recrutement
ACCOMPLISH-2 Research SiteBrooklynNew YorkPas encore en recrutement
ACCOMPLISH-2 Research SiteBurkeVirginiaPas encore en recrutement
ACCOMPLISH-2 Research SiteChandlerArizonaEn recrutement
ACCOMPLISH-2 Research SiteCharlotteNorth CarolinaEn recrutement
ACCOMPLISH-2 Research SiteChesterfieldMissouriPas encore en recrutement
ACCOMPLISH-2 Research SiteCity of Saint PetersMissouriEn recrutement
ACCOMPLISH-2 Research SiteClearwaterFloridaEn recrutement
ACCOMPLISH-2 Research SiteColumbusGeorgiaPas encore en recrutement
ACCOMPLISH-2 Research SiteColumbusOhioEn recrutement
ACCOMPLISH-2 Research SiteDes MoinesIowaEn recrutement
ACCOMPLISH-2 Research SiteDurhamNorth CarolinaPas encore en recrutement
ACCOMPLISH-2 Research SiteEscondidoCaliforniaPas encore en recrutement
ACCOMPLISH-2 Research SiteFarmers BranchTexasPas encore en recrutement
ACCOMPLISH-2 Research SiteFayettevilleNorth CarolinaEn recrutement
ACCOMPLISH-2 Research SiteFort MyersFloridaEn recrutement
ACCOMPLISH-2 Research SiteFountain ValleyCaliforniaEn recrutement
ACCOMPLISH-2 Research SiteGreerSouth CarolinaEn recrutement
ACCOMPLISH-2 Research SiteGulfportMississippiEn recrutement
ACCOMPLISH-2 Research SiteHazelwoodMissouriEn recrutement
ACCOMPLISH-2 Research SiteHoustonTexasEn recrutement
ACCOMPLISH-2 Research SiteHoustonTexasEn recrutement
ACCOMPLISH-2 Research SiteIowa CityIowaPas encore en recrutement
ACCOMPLISH-2 Research SiteJacksonvilleFloridaPas encore en recrutement
ACCOMPLISH-2 Research SiteLa JollaCaliforniaEn recrutement
ACCOMPLISH-2 Research SiteLake ForestCaliforniaPas encore en recrutement
ACCOMPLISH-2 Research SiteLas VegasNevadaPas encore en recrutement
ACCOMPLISH-2 Research SiteLawrencevilleGeorgiaEn recrutement
ACCOMPLISH-2 Research SiteLeesburgFloridaEn recrutement
ACCOMPLISH-2 Research SiteLittle RockArkansasPas encore en recrutement
ACCOMPLISH-2 Research SiteManassasVirginiaEn recrutement
ACCOMPLISH-2 Research SiteMankatoMinnesotaEn recrutement
ACCOMPLISH-2 Research SiteMeridianIdahoEn recrutement
ACCOMPLISH-2 Research SiteMethuenMassachusettsEn recrutement
ACCOMPLISH-2 Research SiteMiamiFloridaPas encore en recrutement
ACCOMPLISH-2 Research SiteMinneapolisMinnesotaEn recrutement
ACCOMPLISH-2 Research SiteMissoulaMontanaEn recrutement
ACCOMPLISH-2 Research SiteMooreOklahomaEn recrutement
ACCOMPLISH-2 Research SiteMorehead CityNorth CarolinaPas encore en recrutement
ACCOMPLISH-2 Research SiteNashvilleTennesseePas encore en recrutement
ACCOMPLISH-2 Research SiteOcalaFloridaEn recrutement
ACCOMPLISH-2 Research SiteOcoeeFloridaEn recrutement
ACCOMPLISH-2 Research SiteOmahaNebraskaPas encore en recrutement
ACCOMPLISH-2 Research SitePembroke PinesFloridaPas encore en recrutement
ACCOMPLISH-2 Research SitePhiladelphiaPennsylvaniaEn recrutement
ACCOMPLISH-2 Research SitePhoenixArizonaPas encore en recrutement

24 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