Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes
4. november 2026 opdateret af: Regeneron Pharmaceuticals
A Phase 2, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Olatorepatide, a GLP-1/GIP Receptor Agonist, With Different Doses and Drug-Titration Algorithms in Participants Living With Overweight or Obesity
This study will test an experimental drug called olatorepatide ("study drug") to determine how safe and effective this drug is compared to placebo and how easily the body can accept this drug at different doses and dosing schedules without causing side effects, as well as how the drug is processed in the body by participants with overweight or obesity but do not have diabetes.
The study is looking at:
- What side effects the study drug might cause
- How much study drug is in the blood at different times
- How well the study drug works
- What effects the study drug may have on the body at different dosing schedules
- If the body makes antibodies to the study drug as this may cause the study drug to not work as well
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
360
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Clinical Trials Administrator
- Telefonnummer: 844-734-6643
- E-mail: clinicaltrials@regeneron.com
Studiesteder
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Alabama
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Mobile, Alabama, Forenede Stater, 36608
- Rekruttering
- AMR Clinical - Mobile
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California
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Walnut Creek, California, Forenede Stater, 94598
- Rekruttering
- Diablo Clinical Research - Flourish Research
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Connecticut
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Waterbury, Connecticut, Forenede Stater, 06708
- Rekruttering
- Chase Medical Research
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Florida
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Doral, Florida, Forenede Stater, 33172
- Rekruttering
- Alliance for Multispecialty Research (AMR) Clinical Miami
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Fort Myers, Florida, Forenede Stater, 33912
- Rekruttering
- AMR Clinical - Fort Myers
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Hialeah, Florida, Forenede Stater, 33012
- Rekruttering
- AGA Clinical Trials
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Inverness, Florida, Forenede Stater, 34452
- Rekruttering
- Flourish Research, Nature Coast Clinical Research
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Jacksonville, Florida, Forenede Stater, 32216
- Rekruttering
- Flourish Research, Jacksonville Center for Clinical Research
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Maitland, Florida, Forenede Stater, 32751
- Rekruttering
- K2 Medical Research Maitland LLC, Main Office
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St. Petersburg, Florida, Forenede Stater, 33704
- Rekruttering
- The IMA Group, IMA Clinical Research St. Petersburg
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The Villages, Florida, Forenede Stater, 32162
- Rekruttering
- Charter Research LLC - The Villages
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Winter Park, Florida, Forenede Stater, 32789
- Rekruttering
- Clinical Site Partners, LLC DBA Flourish Research
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Illinois
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Chicago, Illinois, Forenede Stater, 60618
- Rekruttering
- Charter Research LLC - Chicago
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Chicago, Illinois, Forenede Stater, 60640
- Rekruttering
- Flourish Research, Ravenswood Rheumatology
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Oak Brook, Illinois, Forenede Stater, 60523
- Rekruttering
- AMR Clinical - Chicago Oak Brook
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Kansas
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Wichita, Kansas, Forenede Stater, 67226
- Rekruttering
- AMR Clinical Wichita
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40509
- Rekruttering
- AMR Clinical - Lexington
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68134
- Rekruttering
- Velocity Clinical Research - Omaha
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New York
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New York, New York, Forenede Stater, 10016
- Rekruttering
- NYC Research Inc
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Rochester, New York, Forenede Stater, 14609
- Rekruttering
- Rochester Clinical Research
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South Carolina
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Greenville, South Carolina, Forenede Stater, 29607
- Rekruttering
- Tribe Clinical Research
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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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Key Inclusion Criteria:
- Body Mass Index (BMI) ≥30.0 kg/m^2 to <45.0 kg/m^2 at screening OR
- BMI ≥27.0 kg/m^2 at screening with at least 1 of the following weight-related co-morbidities: Hypertension, Dyslipidemia, Prediabetes, established Obstructive Sleep Apnea (OSA), established Coronary Artery Disease (CAD), Heart failure, established cerebrovascular disease as described in the protocol
Key Exclusion Criteria:
- Previous or current diagnosis of Type 1 or Type 2 diabetes at screening
- Change in body weight >5 kg within approximately 3 months before screening as described in the protocol
- Bariatric surgery, including any procedures to revise, reverse, or remove any previous bariatric surgery interventions as described in the protocol
- History of acute or chronic pancreatitis, cholecystitis, or symptomatic gallbladder stones
- History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
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: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Olatorepatide arm 1
|
Administered per the protocol
Andre navne:
|
|
Eksperimentel: Olatorepatide arm 2
|
Administered per the protocol
Andre navne:
|
|
Eksperimentel: Olatorepatide arm 3
|
Administered per the protocol
Andre navne:
|
|
Eksperimentel: Olatorepatide arm 4
|
Administered per the protocol
Andre navne:
|
|
Eksperimentel: Olatorepatide arm 5
|
Administered per the protocol
Andre navne:
|
|
Aktiv komparator: Matching Placebo arm 6
|
Administered per the protocol |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Tidsramme: Up to approximately 60 weeks
|
Up to approximately 60 weeks
|
|
Severity of TEAEs
Tidsramme: Up to approximately 60 weeks
|
Up to approximately 60 weeks
|
|
Percent change in body weight
Tidsramme: From baseline to week 52
|
From baseline to week 52
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Olatorepatide concentrations
Tidsramme: Up to approximately 60 weeks
|
Up to approximately 60 weeks
|
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Occurrence of Anti-Drug Antibody (ADA) to olatorepatide
Tidsramme: Up to approximately 52 weeks
|
Up to approximately 52 weeks
|
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Magnitude of ADA to olatorepatide
Tidsramme: Up to approximately 52 weeks
|
Up to approximately 52 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Clinical Trial Management, Regeneron Pharmaceuticals
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
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 (Faktiske)
28. juli 2026
Primær færdiggørelse (Anslået)
21. januar 2028
Studieafslutning (Anslået)
21. januar 2028
Datoer for studieregistrering
Først indsendt
29. juni 2026
Først indsendt, der opfyldte QC-kriterier
29. juni 2026
Først opslået (Faktiske)
6. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. november 2026
Sidst verificeret
1. november 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HS-20094-OB-25106
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
IPD-delingstidsramme
When Regeneron has:
- received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
- made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
- the legal authority to share the data, and
- ensured the ability to protect participant privacy
IPD-delingsadgangskriterier
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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 .