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
Sites (60)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Velocity Clinical Research Germany GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Not yet recruiting |
| Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil gGmbH Coordinator of this site? Confirm its status | Bochum | Germany | Not yet recruiting |
| Zentrum für klinische Forschung Koeln Coordinator of this site? Confirm its status | Cologne | Germany | Not yet recruiting |
| Technische Universitaet Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Not yet recruiting |
| Hausaerztlich-Kardiologisches MVZ Am Felsenkeller GmbH Coordinator of this site? Confirm its status | Dresden | Germany | Not yet recruiting |
| MVZ im Altstadt-Carree Fulda GmbH Coordinator of this site? Confirm its status | Fulda | Germany | Not yet recruiting |
| Diabeteszentrum Hamburg West Coordinator of this site? Confirm its status | Hamburg | Germany | Not yet recruiting |
| Siteworks GmbH Coordinator of this site? Confirm its status | Hanover | Germany | Not yet recruiting |
| Siteworks GmbH Coordinator of this site? Confirm its status | Karlsruhe | Germany | Not yet recruiting |
| Familienmedizinisches Zentrum (FMZ) Radowsky Privatpraxis Leipzig Studienzentrum Coordinator of this site? Confirm its status | Leipzig | Germany | Not yet recruiting |
| Institut fuer Diabetesforschung Muenster GmbH Coordinator of this site? Confirm its status | Muenster | Germany | Not yet recruiting |
| Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Coordinator of this site? Confirm its status | Munich | Germany | Not yet recruiting |
| SIGALMED Leipzig Coordinator of this site? Confirm its status | Naunhof | Germany | Not yet recruiting |
| R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH Coordinator of this site? Confirm its status | Oldenburg in Holstein | Germany | Not yet recruiting |
| Hausaeztlich-diabetologische Praxis Coordinator of this site? Confirm its status | Pirna | Germany | Not yet recruiting |
| KliFoCenter GmbH Coordinator of this site? Confirm its status | Witten | Germany | Not yet recruiting |
| Hospital Universitario de Badajoz Coordinator of this site? Confirm its status | Badajoz | Spain | Not yet recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital Universitario De Leon Coordinator of this site? Confirm its status | León | Spain | Not yet recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Not yet recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Not yet recruiting |
| Hospital Virgen del Camino Coordinator of this site? Confirm its status | Sanlúcar de Barrameda | Spain | Not yet recruiting |
| Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional Coordinator of this site? Confirm its status | Sevilla | Spain | Not yet recruiting |
| Hospital Virgen de las Montañas Coordinator of this site? Confirm its status | Villamartín | Spain | Not yet recruiting |
| Lausmed Kft Coordinator of this site? Confirm its status | Baja | Hungary | Not yet recruiting |
| DRC Kft. Coordinator of this site? Confirm its status | Balatonfüred | Hungary | Not yet recruiting |
| Obudai Egeszseguegyi Centrum Kft. Coordinator of this site? Confirm its status | Budapest III | Hungary | Not yet recruiting |
| Strazsahegy Medicina Bt. Coordinator of this site? Confirm its status | Budapest XVII | Hungary | Not yet recruiting |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Not yet recruiting |
| Niepublicznego Zakladu Opieki Zdrowotnej Specjalistyczny Osrodek Internistyczno Diabetologiczny Coordinator of this site? Confirm its status | Bialystok | Poland | Not yet recruiting |
| Centrum Medyczne "Hipokrates" Elżbieta i Grzegorz Grześk Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Not yet recruiting |
| Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Not 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. Coordinator of this site? Confirm its status | Cracow | Poland | Not yet recruiting |
| Centrum Badan Klinicznych PI-House sp. z o.o. Coordinator of this site? Confirm its status | Gdansk | Poland | Not yet recruiting |
| Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii Lek. med. Krzysztof Cymerman Coordinator of this site? Confirm its status | Gdynia | Poland | Not yet recruiting |
| FutureMeds Sp. z o.o. Coordinator of this site? Confirm its status | Gdynia | Poland | Not yet recruiting |
| Osrodek Badan Klinicznych Bd Research Sp. z o.o. Coordinator of this site? Confirm its status | Ilawa | Poland | Not yet recruiting |
| EKAMED sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Not yet recruiting |
| ID Clinic Coordinator of this site? Confirm its status | Myslowice | Poland | Not yet recruiting |
| Ilkowski I Partnerzy sp.p. Lekarzy Coordinator of this site? Confirm its status | Poznan | Poland | Not yet recruiting |
| Centrum Medyczne Medyk Sp. z o.o. S.K. Coordinator of this site? Confirm its status | Rzeszow | Poland | Not yet recruiting |
| Lukmed 2 Sp. z o.o. Coordinator of this site? Confirm its status | Siedlce | Poland | Not yet recruiting |
| Dc-Med Michal Kowalski sp.k. Coordinator of this site? Confirm its status | Swidnica | Poland | Not yet recruiting |
| Balsammedica Sp. z o. o. Coordinator of this site? Confirm its status | Warsaw | Poland | Not yet recruiting |
| Futuremeds Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Not yet recruiting |
| Etg Warszawa Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Not yet recruiting |
| NBR Polska Tomasz Kłodawski Coordinator of this site? Confirm its status | Warszawa | Poland | Not yet recruiting |
| Futuremeds Sp. z o.o. Coordinator of this site? Confirm its status | Wroclaw | Poland | Not yet recruiting |
| Minimed S.R.L. Coordinator of this site? Confirm its status | Bacau | Romania | Not yet recruiting |
| CMI Cardiologie - Dr. Mercea Corina Delia Coordinator of this site? Confirm its status | Baia Mare | Romania | Not yet recruiting |
| Nicodiab S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Not yet recruiting |
| Hightech Medical Services S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Not yet recruiting |
| Institutul Clinic Fundeni Coordinator of this site? Confirm its status | Bucharest | Romania | Not yet recruiting |
| Spitalul Clinic Județean de Urgență Craiova Coordinator of this site? Confirm its status | Craiova | Romania | Not yet recruiting |
| Cardio Med S.R.L. Coordinator of this site? Confirm its status | Craiova | Romania | Not yet recruiting |
| Diamed Obesity S.R.L. Coordinator of this site? Confirm its status | Galati | Romania | Not yet recruiting |
| CMI DIABET TOARBA CRISTINA IOANA Coordinator of this site? Confirm its status | Iasi, | Romania | Not yet recruiting |
| Consultmed S.R.L. Coordinator of this site? Confirm its status | Jassi | Romania | Not yet recruiting |
| CMI Dr Podoleanu Cristian Coordinator of this site? Confirm its status | Târgu Mureş | Romania | Not yet recruiting |
| Institutul de Boli Cardiovasculare Timișoara Coordinator of this site? Confirm its status | Timișoara | Romania | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.