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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

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

In breve

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 partecipanti ricercati71 centri1 paese

Categorie

Endocrino e metabolico83%Cardiovascolare17%

Registrato in 1 registro

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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.

Sintesi

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.

Patologie

  • Obesity
  • Overweight
  • Chronic Weight Management

Idoneità

SessoTutti
Età18 Years – 79 Years
Volontari saniNo

Idoneità come riportata nel 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

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

Tipo di studioInterventistico
FaseFase 3
AssegnazioneRandomizzata
Modello di interventoPARALLEL
Finalità principaleTREATMENT
MascheramentoTRIPLE (3)
Arruolamento3600 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 4EXPERIMENTAL

    Participants will receive placebo administered orally.

Interventi

  • Farmaco Aleniglipron

    Drug: aleniglipron administered orally Drug

  • Farmaco Placebo

    Drug: placebo administered orally

Esiti misurati

  1. Esito primario

    Percent change in body weight from Baseline

    Orizzonte temporale Baseline and Week 76

  2. Esito secondario

    Change in body weight (absolute) from Baseline

    Orizzonte temporale Baseline and week 76

  3. Esito secondario

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

    Orizzonte temporale Baseline and week 76

  4. Esito secondario

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

    Orizzonte temporale Baseline and week 76

  5. Esito secondario

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

    Orizzonte temporale Baseline and week 76

  6. Esito secondario

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

    Orizzonte temporale Baseline and week 76

  9. Esito secondario

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

    Orizzonte temporale Baseline and week 76

  10. Esito secondario

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

    Orizzonte temporale Baseline and week 76

  11. Esito secondario

    Change in HbA1c from Baseline

    Orizzonte temporale Baseline and week 76

  12. Esito secondario

    Change in body mass index from Baseline

    Orizzonte temporale Baseline and week 76

  13. Esito secondario

    Percent change in fasting total cholesterol from Baseline

    Orizzonte temporale Baseline and week 76

  14. Esito secondario

    Change in fasting glucose from Baseline

    Orizzonte temporale Baseline and week 76

  15. Esito secondario

    Change in resting diastolic blood pressure from Baseline

    Orizzonte temporale Baseline and week 76

  16. Altro esito

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

    Orizzonte temporale Baseline and week 76

Date

Data di inizio13 luglio 2026 (effettiva)
Conclusione primaria1 settembre 2028 (stimata)
Conclusione1 novembre 2028 (stimata)
Prima pubblicazione17 giugno 2026 (effettiva)
Ultimo aggiornamento10 agosto 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

13 centri stanno reclutando

United States

StrutturaCittàStato o regioneStato
ACCOMPLISH-1 Research SiteAlbanyNew YorkNon ancora in reclutamento
ACCOMPLISH-1 Research SiteAnn ArborMichiganNon ancora in reclutamento
ACCOMPLISH-1 Research SiteAustinTexasNon ancora in reclutamento
ACCOMPLISH-1 Research SiteAustinTexasIn reclutamento
ACCOMPLISH-1 Research SiteBaton RougeLouisianaNon ancora in reclutamento
ACCOMPLISH-1 Research SiteBirminghamAlabamaNon ancora in reclutamento
ACCOMPLISH-1 Research SiteBirminghamAlabamaNon ancora in reclutamento
ACCOMPLISH-1 Research SiteBrooklynNew YorkNon ancora in reclutamento
ACCOMPLISH-1 Research SiteBufordGeorgiaNon ancora in reclutamento
ACCOMPLISH-1 Research SiteButteMontanaNon ancora in reclutamento
ACCOMPLISH-1 Research SiteCharlotteNorth CarolinaIn reclutamento
ACCOMPLISH-1 Research SiteChesterfieldMissouriNon ancora in reclutamento
ACCOMPLISH-1 Research SiteChicagoIllinoisNon ancora in reclutamento
ACCOMPLISH-1 Research SiteClearwaterFloridaIn reclutamento
ACCOMPLISH-1 Research SiteColumbusOhioIn reclutamento
ACCOMPLISH-1 Research SiteColumbusOhioNon ancora in reclutamento
ACCOMPLISH-1 Research SiteColumbusGeorgiaNon ancora in reclutamento
ACCOMPLISH-1 Research SiteDenisonTexasNon ancora in reclutamento
ACCOMPLISH-1 Research SiteDurhamNorth CarolinaNon ancora in reclutamento
ACCOMPLISH-1 Research SiteEscondidoCaliforniaNon ancora in reclutamento
ACCOMPLISH-1 Research SiteFayettevilleNorth CarolinaNon ancora in reclutamento
ACCOMPLISH-1 Research SiteGardenaCaliforniaNon ancora in reclutamento
ACCOMPLISH-1 Research SiteGreerSouth CarolinaNon ancora in reclutamento
ACCOMPLISH-1 Research SiteGulfportMississippiNon ancora in reclutamento
ACCOMPLISH-1 Research SiteHazelwoodMissouriIn reclutamento
ACCOMPLISH-1 Research SiteHonoluluHawaiiIn reclutamento
ACCOMPLISH-1 Research SiteHoustonTexasNon ancora in reclutamento
ACCOMPLISH-1 Research SiteHoustonTexasNon ancora in reclutamento
ACCOMPLISH-1 Research SiteIowa CityIowaNon ancora in reclutamento
ACCOMPLISH-1 Research SiteKnoxvilleTennesseeNon ancora in reclutamento
ACCOMPLISH-1 Research SiteLa JollaCaliforniaNon ancora in reclutamento
ACCOMPLISH-1 Research SiteLas VegasNevadaNon ancora in reclutamento
ACCOMPLISH-1 Research SiteLawrencevilleGeorgiaNon ancora in reclutamento
ACCOMPLISH-1 Research SiteLeesburgFloridaNon ancora in reclutamento
ACCOMPLISH-1 Research SiteLouisvilleKentuckyNon ancora in reclutamento
ACCOMPLISH-1 Research SiteMankatoMinnesotaIn reclutamento
ACCOMPLISH-1 Research SiteMeridianIdahoNon ancora in reclutamento
ACCOMPLISH-1 Research SiteMethuenMassachusettsNon ancora in reclutamento
ACCOMPLISH-1 Research SiteMiamiFloridaNon ancora in reclutamento
ACCOMPLISH-1 Research SiteMissoulaMontanaNon ancora in reclutamento
ACCOMPLISH-1 Research SiteModestoCaliforniaNon ancora in reclutamento
ACCOMPLISH-1 Research SiteMooreOklahomaNon ancora in reclutamento
ACCOMPLISH-1 Research SiteNeedhamMassachusettsNon ancora in reclutamento
ACCOMPLISH-1 Research SiteNew BernNorth CarolinaNon ancora in reclutamento
ACCOMPLISH-1 Research SiteOcalaFloridaNon ancora in reclutamento
ACCOMPLISH-1 Research SiteOcoeeFloridaNon ancora in reclutamento
ACCOMPLISH-1 Research SiteOmahaNebraskaNon ancora in reclutamento
ACCOMPLISH-1 Research SitePembrokeFloridaNon ancora in reclutamento
ACCOMPLISH-1 Research SitePhiladelphiaPennsylvaniaNon ancora in reclutamento
ACCOMPLISH-1 Research SitePhoenixArizonaNon ancora in reclutamento

Nella scheda del registro sono indicati altri 21 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

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

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