New drug olatorepatide tested for weight loss in adults without diabetes
Tests olatorepatide against a dummy pill in adults with overweight or obesity.
Plain-language title generated from the registry record
Registry title: Efficacy And Safety of Olatorepatide in Adults With Overweight or Obesity Without Diabetes
Key facts
- Where
- Bacau, Baia Mare, Bucharest, Craiova, Galati, Iasi,, Jassi, Târgu Mureş, and Timișoara, RomaniaSee the 12 sites
- Phase
- Phase 3
Where in Romania
- Minimed S.R.L.Bacau, RomaniaNot yet recruiting
- CMI Cardiologie - Dr. Mercea Corina DeliaBaia Mare, RomaniaNot yet recruiting
- Hightech Medical Services S.R.L.Bucharest, RomaniaNot yet recruiting
- Institutul Clinic FundeniBucharest, RomaniaNot yet recruiting
- Nicodiab S.R.L.Bucharest, RomaniaNot yet recruiting
- Cardio Med S.R.L.Craiova, RomaniaNot yet recruiting
- Spitalul Clinic Județean de Urgență CraiovaCraiova, RomaniaNot yet recruiting
- Diamed Obesity S.R.L.Galati, RomaniaNot yet recruiting
- CMI DIABET TOARBA CRISTINA IOANAIasi,, RomaniaNot yet recruiting
- Consultmed S.R.L.Jassi, RomaniaNot yet recruiting
- CMI Dr Podoleanu CristianTârgu Mureş, RomaniaNot yet recruiting
- Institutul de Boli Cardiovasculare TimișoaraTimișoara, RomaniaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Regeneron Pharmaceuticals
- Trial code
- NCT07896265EU 2025-524861-26-00
- Record updated
- 26 October 2026
- Original description
This study will test olatorepatide (study drug) to determine whether it can help treat overweight or obesity.Read full original descriptionShow less
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)
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
Inclusion: 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.
Exclusion: 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; 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.