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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)

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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 Teilnehmende gesucht74 Studienzentren1 Land

Kategorien

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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.

Zusammenfassung

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.

Erkrankungen

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

Eignung

Eignung
GeschlechtAlle
Alter18 Years79 Years
Gesunde FreiwilligeJa

Eignung im Wortlaut des Registers

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.

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

Studiendesign
StudientypInterventionell
PhasePhase 3
ZuteilungRandomisiert
InterventionsmodellPARALLEL
Primäres ZielTREATMENT
VerblindungTRIPLE (3)
Teilnahme1.100 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 4PLACEBO_COMPARATOR

    Participants will receive placebo administered orally.

Interventionen

  • Arzneimittel Placebo

    Drug: placebo administered orally

  • Arzneimittel aleniglipron

    Drug: aleniglipron administered orally

  • Arzneimittel aleniglipron

    Drug: aleniglipron administered orally

  • Arzneimittel aleniglipron

    Drug: aleniglipron administered orally

Endpunkte

  1. Primärer Endpunkt

    Percent change in body weight from Baseline

    Zeitrahmen Baseline and week 76

  2. Sekundärer Endpunkt

    Percentage of participants achieving HbA1c target value of ≤6.5%

    Zeitrahmen Baseline and week 76

  3. Sekundärer Endpunkt

    Change in body weight (absolute) from Baseline

    Zeitrahmen Baseline and week 76

  4. Sekundärer Endpunkt

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

    Zeitrahmen Baseline and week 76

  5. Sekundärer Endpunkt

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

    Zeitrahmen Baseline and week 76

  6. Sekundärer Endpunkt

    Percentage of participants who achieve ≥15% 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 HbA1c from Baseline

    Zeitrahmen Baseline and week 76

  9. Sekundärer Endpunkt

    Change in resting systolic blood pressure from Baseline

    Zeitrahmen Baseline and week 76

  10. Sekundärer Endpunkt

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

    Zeitrahmen Baseline and week 76

Daten

Daten
Startdatum17. Juli 2026 (tatsächlich)
Primärer Abschluss1. September 2028 (geschätzt)
Abschluss1. November 2028 (geschätzt)
Erstveröffentlichung17. Juni 2026 (tatsächlich)
Zuletzt aktualisiert11. September 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

43 Studienzentren rekrutieren

United States

United States
EinrichtungStadtBundesland oder RegionStatus
ACCOMPLISH-2 Research SiteAlbanyNew YorkRekrutierung noch nicht begonnen
ACCOMPLISH-2 Research SiteAlbanyNew YorkRekrutierung noch nicht begonnen
ACCOMPLISH-2 Research SiteAtlantaGeorgiaRekrutiert
ACCOMPLISH-2 Research SiteAustinTexasRekrutiert
ACCOMPLISH-2 Research SiteBirminghamAlabamaRekrutiert
ACCOMPLISH-2 Research SiteBrooklynNew YorkRekrutierung noch nicht begonnen
ACCOMPLISH-2 Research SiteBurkeVirginiaRekrutierung noch nicht begonnen
ACCOMPLISH-2 Research SiteChandlerArizonaRekrutiert
ACCOMPLISH-2 Research SiteCharlotteNorth CarolinaRekrutiert
ACCOMPLISH-2 Research SiteChesterfieldMissouriRekrutierung noch nicht begonnen
ACCOMPLISH-2 Research SiteCity of Saint PetersMissouriRekrutiert
ACCOMPLISH-2 Research SiteClearwaterFloridaRekrutiert
ACCOMPLISH-2 Research SiteColumbusGeorgiaRekrutierung noch nicht begonnen
ACCOMPLISH-2 Research SiteColumbusOhioRekrutiert
ACCOMPLISH-2 Research SiteDes MoinesIowaRekrutiert
ACCOMPLISH-2 Research SiteDurhamNorth CarolinaRekrutierung noch nicht begonnen
ACCOMPLISH-2 Research SiteEscondidoCaliforniaRekrutierung noch nicht begonnen
ACCOMPLISH-2 Research SiteFarmers BranchTexasRekrutierung noch nicht begonnen
ACCOMPLISH-2 Research SiteFayettevilleNorth CarolinaRekrutiert
ACCOMPLISH-2 Research SiteFort MyersFloridaRekrutiert
ACCOMPLISH-2 Research SiteFountain ValleyCaliforniaRekrutiert
ACCOMPLISH-2 Research SiteGreerSouth CarolinaRekrutiert
ACCOMPLISH-2 Research SiteGulfportMississippiRekrutiert
ACCOMPLISH-2 Research SiteHazelwoodMissouriRekrutiert
ACCOMPLISH-2 Research SiteHoustonTexasRekrutiert
ACCOMPLISH-2 Research SiteHoustonTexasRekrutiert
ACCOMPLISH-2 Research SiteIowa CityIowaRekrutierung noch nicht begonnen
ACCOMPLISH-2 Research SiteJacksonvilleFloridaRekrutierung noch nicht begonnen
ACCOMPLISH-2 Research SiteLa JollaCaliforniaRekrutiert
ACCOMPLISH-2 Research SiteLake ForestCaliforniaRekrutierung noch nicht begonnen
ACCOMPLISH-2 Research SiteLas VegasNevadaRekrutierung noch nicht begonnen
ACCOMPLISH-2 Research SiteLawrencevilleGeorgiaRekrutiert
ACCOMPLISH-2 Research SiteLeesburgFloridaRekrutiert
ACCOMPLISH-2 Research SiteLittle RockArkansasRekrutierung noch nicht begonnen
ACCOMPLISH-2 Research SiteManassasVirginiaRekrutiert
ACCOMPLISH-2 Research SiteMankatoMinnesotaRekrutiert
ACCOMPLISH-2 Research SiteMeridianIdahoRekrutiert
ACCOMPLISH-2 Research SiteMethuenMassachusettsRekrutiert
ACCOMPLISH-2 Research SiteMiamiFloridaRekrutierung noch nicht begonnen
ACCOMPLISH-2 Research SiteMinneapolisMinnesotaRekrutiert
ACCOMPLISH-2 Research SiteMissoulaMontanaRekrutiert
ACCOMPLISH-2 Research SiteMooreOklahomaRekrutiert
ACCOMPLISH-2 Research SiteMorehead CityNorth CarolinaRekrutierung noch nicht begonnen
ACCOMPLISH-2 Research SiteNashvilleTennesseeRekrutierung noch nicht begonnen
ACCOMPLISH-2 Research SiteOcalaFloridaRekrutiert
ACCOMPLISH-2 Research SiteOcoeeFloridaRekrutiert
ACCOMPLISH-2 Research SiteOmahaNebraskaRekrutierung noch nicht begonnen
ACCOMPLISH-2 Research SitePembroke PinesFloridaRekrutierung noch nicht begonnen
ACCOMPLISH-2 Research SitePhiladelphiaPennsylvaniaRekrutiert
ACCOMPLISH-2 Research SitePhoenixArizonaRekrutierung noch nicht begonnen

24 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