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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)

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
Contatta questo studio

In breve

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 partecipanti ricercati74 centri1 paese

Categorie

Registrato in 1 registro

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Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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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.

Sintesi

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.

Patologie

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

Idoneità

Idoneità
SessoTutti
Età18 Years79 Years
Volontari sani

Idoneità come riportata nel 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.

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Disegno dello studio
Tipo di studioInterventistico
FaseFase 3
AssegnazioneRandomizzata
Modello di interventoPARALLEL
Finalità principaleTREATMENT
MascheramentoTRIPLE (3)
Arruolamento1100 partecipanti ricercati

Sponsor e collaboratori

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

Bracci e interventi

  • 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.

Interventi

  • Farmaco Placebo

    Drug: placebo administered orally

  • Farmaco aleniglipron

    Drug: aleniglipron administered orally

  • Farmaco aleniglipron

    Drug: aleniglipron administered orally

  • Farmaco aleniglipron

    Drug: aleniglipron administered orally

Esiti misurati

  1. Esito primario

    Percent change in body weight from Baseline

    Orizzonte temporale Baseline and week 76

  2. Esito secondario

    Percentage of participants achieving HbA1c target value of ≤6.5%

    Orizzonte temporale Baseline and week 76

  3. Esito secondario

    Change in body weight (absolute) from Baseline

    Orizzonte temporale Baseline and week 76

  4. Esito secondario

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

    Orizzonte temporale Baseline and week 76

  5. Esito secondario

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

    Orizzonte temporale Baseline and week 76

  6. Esito secondario

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

    Orizzonte temporale Baseline and week 76

  7. Esito secondario

    Change in waist circumference from Baseline

    Orizzonte temporale Baseline and week 76

  8. Esito secondario

    Change in HbA1c from Baseline

    Orizzonte temporale Baseline and week 76

  9. Esito secondario

    Change in resting systolic blood pressure from Baseline

    Orizzonte temporale Baseline and week 76

  10. Esito secondario

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

    Orizzonte temporale Baseline and week 76

Date

Date
Data di inizio17 luglio 2026 (effettiva)
Conclusione primaria1 settembre 2028 (stimata)
Conclusione1 novembre 2028 (stimata)
Prima pubblicazione17 giugno 2026 (effettiva)
Ultimo aggiornamento11 settembre 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltagiugno 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

43 centri stanno reclutando

United States

United States
StrutturaCittàStato o regioneStato
ACCOMPLISH-2 Research SiteAlbanyNew YorkNon ancora in reclutamento
ACCOMPLISH-2 Research SiteAlbanyNew YorkNon ancora in reclutamento
ACCOMPLISH-2 Research SiteAtlantaGeorgiaIn reclutamento
ACCOMPLISH-2 Research SiteAustinTexasIn reclutamento
ACCOMPLISH-2 Research SiteBirminghamAlabamaIn reclutamento
ACCOMPLISH-2 Research SiteBrooklynNew YorkNon ancora in reclutamento
ACCOMPLISH-2 Research SiteBurkeVirginiaNon ancora in reclutamento
ACCOMPLISH-2 Research SiteChandlerArizonaIn reclutamento
ACCOMPLISH-2 Research SiteCharlotteNorth CarolinaIn reclutamento
ACCOMPLISH-2 Research SiteChesterfieldMissouriNon ancora in reclutamento
ACCOMPLISH-2 Research SiteCity of Saint PetersMissouriIn reclutamento
ACCOMPLISH-2 Research SiteClearwaterFloridaIn reclutamento
ACCOMPLISH-2 Research SiteColumbusGeorgiaNon ancora in reclutamento
ACCOMPLISH-2 Research SiteColumbusOhioIn reclutamento
ACCOMPLISH-2 Research SiteDes MoinesIowaIn reclutamento
ACCOMPLISH-2 Research SiteDurhamNorth CarolinaNon ancora in reclutamento
ACCOMPLISH-2 Research SiteEscondidoCaliforniaNon ancora in reclutamento
ACCOMPLISH-2 Research SiteFarmers BranchTexasNon ancora in reclutamento
ACCOMPLISH-2 Research SiteFayettevilleNorth CarolinaIn reclutamento
ACCOMPLISH-2 Research SiteFort MyersFloridaIn reclutamento
ACCOMPLISH-2 Research SiteFountain ValleyCaliforniaIn reclutamento
ACCOMPLISH-2 Research SiteGreerSouth CarolinaIn reclutamento
ACCOMPLISH-2 Research SiteGulfportMississippiIn reclutamento
ACCOMPLISH-2 Research SiteHazelwoodMissouriIn reclutamento
ACCOMPLISH-2 Research SiteHoustonTexasIn reclutamento
ACCOMPLISH-2 Research SiteHoustonTexasIn reclutamento
ACCOMPLISH-2 Research SiteIowa CityIowaNon ancora in reclutamento
ACCOMPLISH-2 Research SiteJacksonvilleFloridaNon ancora in reclutamento
ACCOMPLISH-2 Research SiteLa JollaCaliforniaIn reclutamento
ACCOMPLISH-2 Research SiteLake ForestCaliforniaNon ancora in reclutamento
ACCOMPLISH-2 Research SiteLas VegasNevadaNon ancora in reclutamento
ACCOMPLISH-2 Research SiteLawrencevilleGeorgiaIn reclutamento
ACCOMPLISH-2 Research SiteLeesburgFloridaIn reclutamento
ACCOMPLISH-2 Research SiteLittle RockArkansasNon ancora in reclutamento
ACCOMPLISH-2 Research SiteManassasVirginiaIn reclutamento
ACCOMPLISH-2 Research SiteMankatoMinnesotaIn reclutamento
ACCOMPLISH-2 Research SiteMeridianIdahoIn reclutamento
ACCOMPLISH-2 Research SiteMethuenMassachusettsIn reclutamento
ACCOMPLISH-2 Research SiteMiamiFloridaNon ancora in reclutamento
ACCOMPLISH-2 Research SiteMinneapolisMinnesotaIn reclutamento
ACCOMPLISH-2 Research SiteMissoulaMontanaIn reclutamento
ACCOMPLISH-2 Research SiteMooreOklahomaIn reclutamento
ACCOMPLISH-2 Research SiteMorehead CityNorth CarolinaNon ancora in reclutamento
ACCOMPLISH-2 Research SiteNashvilleTennesseeNon ancora in reclutamento
ACCOMPLISH-2 Research SiteOcalaFloridaIn reclutamento
ACCOMPLISH-2 Research SiteOcoeeFloridaIn reclutamento
ACCOMPLISH-2 Research SiteOmahaNebraskaNon ancora in reclutamento
ACCOMPLISH-2 Research SitePembroke PinesFloridaNon ancora in reclutamento
ACCOMPLISH-2 Research SitePhiladelphiaPennsylvaniaIn reclutamento
ACCOMPLISH-2 Research SitePhoenixArizonaNon ancora in reclutamento

Nella scheda del registro sono indicati altri 24 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

  1. 10 agosto 2026

    Stato modificato

    Status changed from Not yet recruiting to Recruiting

    NOT_YET_RECRUITINGRECRUITING

  2. 10 agosto 2026

    Reclutamento aperto

    Recruitment opened

    NOT_YET_RECRUITINGRECRUITING