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A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)

12. juni 2026 opdateret af: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

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)

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1100

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cohort 1
Participants will receive aleniglipron administered orally.
Medicin: aleniglipron
Drug: aleniglipron administered orally
Eksperimentel: Cohort 2
Participants will receive aleniglipron administered orally.
Medicin: aleniglipron
Drug: aleniglipron administered orally
Eksperimentel: Cohort 3
Participants will receive aleniglipron administered orally.
Medicin: aleniglipron
Drug: aleniglipron administered orally
Placebo komparator: Cohort 4
Participants will receive placebo administered orally.
Medicin: Placebo
Drug: placebo administered orally

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Percent change in body weight from Baseline
Tidsramme: Baseline and week 76
Baseline and week 76

Sekundære resultatmål

Resultatmål
Tidsramme
Change in body weight (absolute) from Baseline
Tidsramme: Baseline and week 76
Baseline and week 76
Percentage of participants who achieve ≥5% reduction in body weight
Tidsramme: Baseline and week 76
Baseline and week 76
Percentage of participants who achieve ≥10% reduction in body weight
Tidsramme: Baseline and week 76
Baseline and week 76
Percentage of participants who achieve ≥15% reduction in body weight
Tidsramme: Baseline and week 76
Baseline and week 76
Change in waist circumference from Baseline
Tidsramme: Baseline and week 76
Baseline and week 76
Change in HbA1c from Baseline
Tidsramme: Baseline and week 76
Baseline and week 76
Change in resting systolic blood pressure from Baseline
Tidsramme: Baseline and week 76
Baseline and week 76
Percent change in fasting triglycerides and non-HDL cholesterol from Baseline
Tidsramme: Baseline and week 76
Baseline and week 76
Percentage of participants achieving HbA1c target value of ≤6.5%
Tidsramme: Baseline and week 76
Baseline and week 76

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. september 2028

Studieafslutning (Anslået)

1. november 2028

Datoer for studieregistrering

Først indsendt

12. juni 2026

Først indsendt, der opfyldte QC-kriterier

12. juni 2026

Først opslået (Faktiske)

17. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GSBR-1290-15

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual patient data for variables necessary to address a specific research question in an approved data sharing request

IPD-delingstidsramme

Data sharing requests will be considered beginning 36 months after the study publication (manuscript accepted for publication) and either 1) the product has been granted marketing authorization in at least two regulatory jurisdictions, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD-delingsadgangskriterier

Researchers will submit a request containing the research objectives, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). Gasherbrum Bio, Inc. does not grant external requests for individual de-identified patient data for the following purposes:

  • Re-evaluating safety and efficacy end points already addressed in the product labelling,
  • Assessing safety or efficacy for an indication in current development Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a panel of external advisors. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med aleniglipron

Søg i lignende forsøg

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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