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
- Badajoz, Barcelona, León, Málaga, Sanlúcar de Barrameda, Sevilla, and Villamartín, SpainSee the 8 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who are overweight or obese and do not have diabetes. It will test the study drug olatorepatide against placebo.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- BMI ≥30.0 kg/m^2, or BMI ≥27.0 kg/m^2 with at least 1 weight-related health problem: high blood pressure, abnormal blood fats (dyslipidemia), prediabetes, sleep apnea (OSA), coronary artery disease (CAD), heart failure or cerebrovascular disease
- Earlier treatment
- Must have tried to lose weight by diet at least once without success. Must not have used GLP-1-RA, GLP-1/GIP RA or similar drugs in the 90 days before screening.
- Biomarker or test result
- HbA1c must be below 6.5% (48 mmol/mol) at screening
Main reasons for not taking part
- Diagnosis of type 1 or type 2 diabetes, or HbA1c ≥6.5% (48 mmol/mol)
- Body weight change of more than 5 kg (11 lb) in the 90 days before randomization
- Treatment in the 90 days before screening that causes weight loss or weight gain
- Previous or planned bariatric surgery
Read by machine on 9 November 2026.
Where in Spain
- Hospital Universitario de BadajozBadajoz, SpainNot yet recruiting
- Hospital Universitari Vall d'HebronBarcelona, SpainNot yet recruiting
- Hospital Universitario De LeonLeón, SpainNot yet recruiting
- Hospital Universitario Regional de MálagaMálaga, SpainNot yet recruiting
- Hospital Universitario Virgen de la VictoriaMálaga, SpainNot yet recruiting
- Hospital Virgen del CaminoSanlúcar de Barrameda, SpainNot yet recruiting
- Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. ProfesionalSevilla, SpainNot yet recruiting
- Hospital Virgen de las MontañasVillamartín, SpainNot 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.