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NCT07896265Not yet recruitingPhase 3

Efficacy And Safety of Olatorepatide in Adults With Overweight or Obesity Without Diabetes

A Phase 3, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Olatorepatide, a GLP-1/GIP Receptor Agonist, in Participants Living With Overweight or Obesity Without Diabetes (RISE-1)

Source: ClinicalTrials.gov · Last updated 26 Oct 2026

Brief summary (registry, in English)

This study will test olatorepatide (study drug) to determine whether it can help treat overweight or obesity. In this study we will test how safe and how well olatorepatide works compared to placebo in people who are overweight or obese but do not have diabetes. The study is looking at: * How well the study drug works * How the body and blood and urine biomarkers change after taking the study drug, which can help researchers understand why the study drug may work better in some people than in others * What side effects the study drug might cause * How much of the study drug is in the blood at different times * If the body makes antibodies to the study drug this may cause the study drug to not work as well

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
3000 (estimated)
First submitted
19 Oct 2026
Start date
18 Nov 2026
Primary completion date
19 Dec 2028
Lead sponsor
Regeneron Pharmaceuticals
Diseases
Obesity
NCT number
NCT07896265
EU CT number
2025-524861-26-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 3000
  • From 18 Nov 2026 to the primary completion date, 19 Dec 2028
  • 60 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Change in body weight \>5 kg within 90 days prior to randomization as described in the protocol
  • Current use or previous treatment in 90 days prior to screening with GLP-1-RA, GLP-1/GIP RA, related molecule, or any other Nutrient-Stimulated Hormone (NuSH)-based therapy
  • Current treatment or treatment in 90 days prior to screening associated with weight loss or weight gain or high risk of initiation of such a treatment during the study duration as described in the protocol
  • Previous or planned bariatric surgery
    • Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Lab values

  • Have previous or current diagnosis of diabetes, including Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D) or screening HbA1c ≥6.5% as described in the protocol

Who the study is looking for

  • Has BMI ≥30.0 kg/m\^2 at screening OR BMI ≥27.0 kg/m\^2 at screening with at least 1 of the following weight-related comorbidities: Hypertension, Dyslipidemia, Prediabetes, established Obstructive Sleep Apnea (OSA), established Coronary Artery Disease (CAD), Heart failure, established cerebrovascular disease, as described in the protocol
  • History of one or more self-reported unsuccessful dietary attempts to lose weight

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (60)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Velocity Clinical Research Germany GmbH
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BerlinGermanyNot yet recruiting
Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil gGmbH
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BochumGermanyNot yet recruiting
Zentrum für klinische Forschung Koeln
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CologneGermanyNot yet recruiting
Technische Universitaet Dresden
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DresdenGermanyNot yet recruiting
Hausaerztlich-Kardiologisches MVZ Am Felsenkeller GmbH
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DresdenGermanyNot yet recruiting
MVZ im Altstadt-Carree Fulda GmbH
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FuldaGermanyNot yet recruiting
Diabeteszentrum Hamburg West
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HamburgGermanyNot yet recruiting
Siteworks GmbH
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HanoverGermanyNot yet recruiting
Siteworks GmbH
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KarlsruheGermanyNot yet recruiting
Familienmedizinisches Zentrum (FMZ) Radowsky Privatpraxis Leipzig Studienzentrum
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LeipzigGermanyNot yet recruiting
Institut fuer Diabetesforschung Muenster GmbH
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MuensterGermanyNot yet recruiting
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
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MunichGermanyNot yet recruiting
SIGALMED Leipzig
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NaunhofGermanyNot yet recruiting
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
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Oldenburg in HolsteinGermanyNot yet recruiting
Hausaeztlich-diabetologische Praxis
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PirnaGermanyNot yet recruiting
KliFoCenter GmbH
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WittenGermanyNot yet recruiting
Hospital Universitario de Badajoz
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BadajozSpainNot yet recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainNot yet recruiting
Hospital Universitario De Leon
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LeónSpainNot yet recruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainNot yet recruiting
Hospital Universitario Regional de Málaga
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MálagaSpainNot yet recruiting
Hospital Virgen del Camino
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Sanlúcar de BarramedaSpainNot yet recruiting
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional
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SevillaSpainNot yet recruiting
Hospital Virgen de las Montañas
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VillamartínSpainNot yet recruiting
Lausmed Kft
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BajaHungaryNot yet recruiting
DRC Kft.
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BalatonfüredHungaryNot yet recruiting
Obudai Egeszseguegyi Centrum Kft.
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Budapest IIIHungaryNot yet recruiting
Strazsahegy Medicina Bt.
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Budapest XVIIHungaryNot yet recruiting
University of Debrecen
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DebrecenHungaryNot yet recruiting
Niepublicznego Zakladu Opieki Zdrowotnej Specjalistyczny Osrodek Internistyczno Diabetologiczny
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BialystokPolandNot yet recruiting
Centrum Medyczne "Hipokrates" Elżbieta i Grzegorz Grześk
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BydgoszczPolandNot yet recruiting
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o.
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CracowPolandNot yet recruiting
Unicardia Specjalistyczne Centrum Leczenia Chorob Serca I Naczyn & Unimedica Specjalistyczne Centrum Medyczne & Uniestetica Centrum Chirurgii Plastycznej Rekonstrukcyjnej I Medycyny Estetycznej Malopolskie Kliniki Specjalistyczne Sp. z o.o.
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CracowPolandNot yet recruiting
Centrum Badan Klinicznych PI-House sp. z o.o.
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GdanskPolandNot yet recruiting
Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii Lek. med. Krzysztof Cymerman
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GdyniaPolandNot yet recruiting
FutureMeds Sp. z o.o.
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GdyniaPolandNot yet recruiting
Osrodek Badan Klinicznych Bd Research Sp. z o.o.
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IlawaPolandNot yet recruiting
EKAMED sp. z o.o.
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LublinPolandNot yet recruiting
ID Clinic
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MyslowicePolandNot yet recruiting
Ilkowski I Partnerzy sp.p. Lekarzy
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PoznanPolandNot yet recruiting
Centrum Medyczne Medyk Sp. z o.o. S.K.
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RzeszowPolandNot yet recruiting
Lukmed 2 Sp. z o.o.
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SiedlcePolandNot yet recruiting
Dc-Med Michal Kowalski sp.k.
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SwidnicaPolandNot yet recruiting
Balsammedica Sp. z o. o.
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WarsawPolandNot yet recruiting
Futuremeds Sp. z o.o.
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WarsawPolandNot yet recruiting
Etg Warszawa Sp. z o.o.
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WarsawPolandNot yet recruiting
NBR Polska Tomasz Kłodawski
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WarszawaPolandNot yet recruiting
Futuremeds Sp. z o.o.
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WroclawPolandNot yet recruiting
Minimed S.R.L.
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BacauRomaniaNot yet recruiting
CMI Cardiologie - Dr. Mercea Corina Delia
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Baia MareRomaniaNot yet recruiting
Nicodiab S.R.L.
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BucharestRomaniaNot yet recruiting
Hightech Medical Services S.R.L.
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BucharestRomaniaNot yet recruiting
Institutul Clinic Fundeni
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BucharestRomaniaNot yet recruiting
Spitalul Clinic Județean de Urgență Craiova
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CraiovaRomaniaNot yet recruiting
Cardio Med S.R.L.
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CraiovaRomaniaNot yet recruiting
Diamed Obesity S.R.L.
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GalatiRomaniaNot yet recruiting
CMI DIABET TOARBA CRISTINA IOANA
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Iasi,RomaniaNot yet recruiting
Consultmed S.R.L.
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JassiRomaniaNot yet recruiting
CMI Dr Podoleanu Cristian
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Târgu MureşRomaniaNot yet recruiting
Institutul de Boli Cardiovasculare Timișoara
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TimișoaraRomaniaNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.