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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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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 Teilnehmende gesucht71 Studienzentren1 Land

Kategorien

Endokrin und metabolisch83%Herz-Kreislauf17%

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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.

Zusammenfassung

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.

Erkrankungen

  • Obesity
  • Overweight
  • Chronic Weight Management

Eignung

GeschlechtAlle
Alter18 Years – 79 Years
Gesunde FreiwilligeNein

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

StudientypInterventionell
PhasePhase 3
ZuteilungRandomisiert
InterventionsmodellPARALLEL
Primäres ZielTREATMENT
VerblindungTRIPLE (3)
Teilnahme3.600 Teilnehmende gesucht

Sponsor und Mitwirkende

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

Studienarme und Interventionen

  • 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.

Interventionen

  • Arzneimittel Aleniglipron

    Drug: aleniglipron administered orally Drug

  • Arzneimittel Placebo

    Drug: placebo administered orally

Endpunkte

  1. Primärer Endpunkt

    Percent change in body weight from Baseline

    Zeitrahmen Baseline and Week 76

  2. Sekundärer Endpunkt

    Change in body weight (absolute) from Baseline

    Zeitrahmen Baseline and week 76

  3. Sekundärer Endpunkt

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

    Zeitrahmen Baseline and week 76

  4. Sekundärer Endpunkt

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

    Zeitrahmen Baseline and week 76

  5. Sekundärer Endpunkt

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

    Zeitrahmen Baseline and week 76

  6. Sekundärer Endpunkt

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

    Zeitrahmen Baseline and week 76

  7. Sekundärer Endpunkt

    Change in waist circumference from Baseline

    Zeitrahmen Baseline and week 76

  8. Sekundärer Endpunkt

    Change in resting systolic blood pressure from Baseline

    Zeitrahmen Baseline and week 76

  9. Sekundärer Endpunkt

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

    Zeitrahmen Baseline and week 76

  10. Sekundärer Endpunkt

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

    Zeitrahmen Baseline and week 76

  11. Sekundärer Endpunkt

    Change in HbA1c from Baseline

    Zeitrahmen Baseline and week 76

  12. Sekundärer Endpunkt

    Change in body mass index from Baseline

    Zeitrahmen Baseline and week 76

  13. Sekundärer Endpunkt

    Percent change in fasting total cholesterol from Baseline

    Zeitrahmen Baseline and week 76

  14. Sekundärer Endpunkt

    Change in fasting glucose from Baseline

    Zeitrahmen Baseline and week 76

  15. Sekundärer Endpunkt

    Change in resting diastolic blood pressure from Baseline

    Zeitrahmen Baseline and week 76

  16. Sonstiger Endpunkt

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

    Zeitrahmen Baseline and week 76

Daten

Startdatum13. Juli 2026 (tatsächlich)
Primärer Abschluss1. September 2028 (geschätzt)
Abschluss1. November 2028 (geschätzt)
Erstveröffentlichung17. Juni 2026 (tatsächlich)
Zuletzt aktualisiert10. August 2026
Ergebnisse veröffentlichtIm Registereintrag nicht angegeben
Status zuletzt bestätigtJuni 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

13 Studienzentren rekrutieren

United States

EinrichtungStadtBundesland oder RegionStatus
ACCOMPLISH-1 Research SiteAlbanyNew YorkRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteAnn ArborMichiganRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteAustinTexasRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteAustinTexasRekrutiert
ACCOMPLISH-1 Research SiteBaton RougeLouisianaRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteBirminghamAlabamaRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteBirminghamAlabamaRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteBrooklynNew YorkRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteBufordGeorgiaRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteButteMontanaRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteCharlotteNorth CarolinaRekrutiert
ACCOMPLISH-1 Research SiteChesterfieldMissouriRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteChicagoIllinoisRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteClearwaterFloridaRekrutiert
ACCOMPLISH-1 Research SiteColumbusOhioRekrutiert
ACCOMPLISH-1 Research SiteColumbusOhioRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteColumbusGeorgiaRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteDenisonTexasRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteDurhamNorth CarolinaRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteEscondidoCaliforniaRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteFayettevilleNorth CarolinaRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteGardenaCaliforniaRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteGreerSouth CarolinaRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteGulfportMississippiRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteHazelwoodMissouriRekrutiert
ACCOMPLISH-1 Research SiteHonoluluHawaiiRekrutiert
ACCOMPLISH-1 Research SiteHoustonTexasRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteHoustonTexasRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteIowa CityIowaRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteKnoxvilleTennesseeRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteLa JollaCaliforniaRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteLas VegasNevadaRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteLawrencevilleGeorgiaRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteLeesburgFloridaRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteLouisvilleKentuckyRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteMankatoMinnesotaRekrutiert
ACCOMPLISH-1 Research SiteMeridianIdahoRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteMethuenMassachusettsRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteMiamiFloridaRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteMissoulaMontanaRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteModestoCaliforniaRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteMooreOklahomaRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteNeedhamMassachusettsRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteNew BernNorth CarolinaRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteOcalaFloridaRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteOcoeeFloridaRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SiteOmahaNebraskaRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SitePembrokeFloridaRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SitePhiladelphiaPennsylvaniaRekrutierung noch nicht begonnen
ACCOMPLISH-1 Research SitePhoenixArizonaRekrutierung noch nicht begonnen

21 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

  1. 10. August 2026

    Status geändert

    Status changed from Not yet recruiting to Recruiting

    NOT_YET_RECRUITINGRECRUITING

  2. 10. August 2026

    Rekrutierung eröffnet

    Recruitment opened

    NOT_YET_RECRUITINGRECRUITING

Register: ClinicalTrials.gov · NCT########

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