A Study to Investigate the Efficacy and Safety of Elecoglipron in Asian Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus (Elecoglipron)
A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Evaluate the Efficacy and Safety of Elecoglipron in Asian Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus (EMBOLD-Asia)
The purpose of this study is to evaluate the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adult participants living with obesity or overweight with or without T2DM.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a Phase III, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of oral elecoglipron in adults with obesity or overweight, with or without type 2 diabetes mellitus. Participants will be randomized to receive elecoglipron or placebo in accordance with the study protocol. Efficacy and safety will be assessed throughout the study.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: AstraZeneca Clinical Study Information Center
- Telefonnummer: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Studiesteder
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Davao City, Filippinerne, PH-8000
- Ikke rekrutterer endnu
- Research Site
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Iloilo City, Filippinerne, 5000
- Ikke rekrutterer endnu
- Research Site
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Manila, Filippinerne, 1000
- Ikke rekrutterer endnu
- Research Site
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Hong Kong, Hong Kong, 999077
- Rekruttering
- Research Site
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Shatin, Hong Kong, Hong Kong
- Rekruttering
- Research Site
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Baotou, Kina, 014040
- Ikke rekrutterer endnu
- Research Site
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Beijing, Kina, 100044
- Rekruttering
- Research Site
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Beijing, Kina, 102218
- Ikke rekrutterer endnu
- Research Site
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Beijing, Kina, 100050
- Rekruttering
- Research Site
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Changde, Kina, 415000
- Rekruttering
- Research Site
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Changsha, Kina, 410015
- Rekruttering
- Research Site
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Changzhou, Kina, 213000
- Rekruttering
- Research Site
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Chengdu, Kina, 611130
- Rekruttering
- Research Site
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Hefei, Kina, 230601
- Rekruttering
- Research Site
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Huangshi, Kina, 435000
- Rekruttering
- Research Site
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Jincheng, Kina, 048000
- Rekruttering
- Research Site
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Jinzhou Shi, Kina, 121001
- Ikke rekrutterer endnu
- Research Site
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Langfang, Kina, 065000
- Rekruttering
- Research Site
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Luoyang, Kina, 471009
- Ikke rekrutterer endnu
- Research Site
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Meihekou, Kina, 135022
- Rekruttering
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Nanjing, Kina, 210011
- Rekruttering
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Nanyang, Kina, 473000
- Rekruttering
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Nanyang, Kina, 473009
- Rekruttering
- Research Site
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Shanghai, Kina, 201199
- Rekruttering
- Research Site
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Shantou, Kina, 515065
- Rekruttering
- Research Site
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Shenyang, Kina, 110004
- Rekruttering
- Research Site
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Shenyang, Kina, 110023
- Rekruttering
- Research Site
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Shijiazhuang, Kina, 050001
- Rekruttering
- Research Site
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Wuhan, Kina, 430010
- Trukket tilbage
- Research Site
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Wuhu, Kina, 241004
- Rekruttering
- Research Site
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Xianyang, Kina, 712000
- Rekruttering
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Xuzhou, Kina, 221000
- Rekruttering
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Yan’an, Kina, 716000
- Rekruttering
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Yueyang, Kina, 414000
- Rekruttering
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Zhumadian, Kina, 463000
- Rekruttering
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Zibo, Kina, 255499
- Rekruttering
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Alor Star, Malaysia, 5460
- Rekruttering
- Research Site
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Kuala Lumpur, Malaysia, 59100
- Rekruttering
- Research Site
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Kuching, Malaysia, 93586
- Rekruttering
- Research Site
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Putrajaya, Malaysia, 62250
- Rekruttering
- Research Site
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Sarawak Miri, Malaysia, 98000
- Rekruttering
- Research Site
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Seremban, Malaysia, 70300
- Ikke rekrutterer endnu
- Research Site
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Seri Manjung, Malaysia, 32040
- Rekruttering
- Research Site
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Sungai Buloh, Malaysia, 47000
- Rekruttering
- Research Site
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Bangkok, Thailand, 10400
- Rekruttering
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Bangkok, Thailand, 10700
- Rekruttering
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Chiang Mai, Thailand, 50200
- Rekruttering
- Research Site
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Phutthamonthon, Thailand, 73170
- Rekruttering
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Songkhla, Thailand, 90110
- Rekruttering
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Adult participant aged 18 years or older at the time of informed consent.
- Body mass index (BMI) at screening of:
- 28 kg/m^2 or higher, or
- 24 kg/m^2 to less than 28 kg/m^2 with at least 1 weight-related comorbidity.
- Stable body weight (self-reported or documented) for 90 days prior to the screening visit (± 5% body weight change)
- History of at least 1 self-reported unsuccessful dietary effort to lose body weight.
- Participants with type 2 diabetes mellitus, if enrolled, and have HbA1c from 6.5% to less than 10.0% at screening.
Exclusion Criteria:
- Any of the following medical history, laboratory values, or complications related to diabetes:
- T1DM
- HbA1c ≥ 10% (86 mmol/mol) at the screening visit
- Currently receiving, or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema.
- Have had more than one episode of severe hypoglycemia within 180 days prior to the screening visit, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
- History of acute (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy) or chronic pancreatitis.
- History/family history (first degree biologic relatives) of medullary thyroid cancer or multiple endocrine neoplasia type 2.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Arm 1 - Dose 1
Active IMP |
Elecoglipron film coated tablet once daily |
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Eksperimentel: Arm 2 - Dose 2
Active IMP |
Elecoglipron film coated tablet once daily |
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Placebo komparator: Arm 3 - Placebo
Placebo matching elecoglipron |
Placebo matching elecoglipron film-coated tablet once daily |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Percent change from baseline to Week 52 in body weight
Tidsramme: Week 52
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Percent change from baseline to Week 52 in body weight. |
Week 52
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Participants achieving at least 5% body weight loss at Week 52
Tidsramme: Week 52
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Achieved at least 5% body weight loss from baseline at Week 52. |
Week 52
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Participants achieving at least 10% body weight loss at Week 52
Tidsramme: Week 52
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Achieved at least 10% body weight loss from baseline at Week 52. |
Week 52
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Change in waist circumference from baseline to Week 52
Tidsramme: Week 52
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Absolute change from baseline to Week 52 in waist circumference(cm). |
Week 52
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i det endokrine system
- Ernæringsforstyrrelser
- Metaboliske sygdomme
- Overernæring
- Kropsvægt
- Ændringer i kropsvægt
- Glukosemetabolismeforstyrrelser
- Diabetes mellitus
- Patologiske tilstande, tegn og symptomer
- Ernæringsmæssige og metaboliske sygdomme
- Tegn og symptomer
- Overvægtig
- Fedme
- Vægttab
- Diabetes mellitus, type 2
Andre undersøgelses-id-numre
- D7260C00022
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD-delingstidsramme
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD-delingsadgangskriterier
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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