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Phase 3 Double‑Blind Study of Olatorepatide for Weight Loss in Adults with Overweight or Obesity Without Diabetes

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial focuses on adults who are classified as Overweight or Obesity without Diabetes. The medication being tested is called Olatorepatide, which works as a GLP-1/GIP Receptor Agonist. Participants will receive either the study drug or a placebo. The main goal is to see if the drug can produce greater loss of body weight compared with the control.

During the study, participants will receive a subcutaneous injection of the assigned product once a week for several months. They will attend regular clinic visits where simple measurements such as weight, waist circumference, systolic blood pressure and diastolic blood pressure are taken, along with blood tests that look at hemoglobin A1C, fasting plasma glucose, and levels of cholesterol and other fats. Additional blood and urine checks evaluate markers like high-sensitivity C-Reactive Protein and urine albumin-creatinine ratio. Questionnaires are used to assess changes in quality of life. Safety will be monitored by recording any side effects that appear.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and randomization

    After signing the consent form, you will be assigned to receive either the study drug olatorepatide or a matching placebo without knowing which one you receive.

    The assignment is done by a computer system to keep the study double‑blind.

  2. Step 2

    Baseline assessments

    Before the first injection, study staff will measure your body weight, waist circumference, and blood pressure.

    Blood samples will be taken to check cholesterol, blood sugar, hemoglobin a1c, fasting plasma glucose, high‑sensitivity c‑reactive protein, and urine albumin‑creatinine ratio.

    Questionnaires about quality of life related to weight will be completed.

  3. Step 3

    Study drug administration

    You will receive a subcutaneous injection of either olatorepatide or placebo as a solution for injection.

    The dose listed in the protocol is 00 mg; the exact schedule (for example, weekly or monthly) will be explained by the study staff.

    Injections will continue for the duration of the treatment period defined by the study.

  4. Step 4

    Regular follow‑up visits

    At each scheduled visit you will have your body weight, waist circumference, and blood pressure measured again.

    Blood samples will be taken to monitor cholesterol levels, blood sugar, hemoglobin a1c, fasting plasma glucose, high‑sensitivity c‑reactive protein, and kidney function markers.

    You will be asked about any side effects or adverse events you may have experienced.

    The study team may also measure the amount of olatorepatide in your blood and test for antibodies that could develop against the drug.

  5. Step 5

    End‑of‑treatment assessment

    When the treatment period ends, a final set of measurements will be performed, including body weight, waist circumference, blood pressure, and the same laboratory tests as earlier visits.

    You will complete the quality‑of‑life questionnaire a last time.

  6. Step 6

    Post‑study follow‑up

    After the study ends, you may be contacted for a short safety check to ensure no late‑appearing side effects have occurred.

Who can join the trial?

4 criteria

  • Body mass index (BMI) must be 30 or higher. If your BMI is between 27 and 30, you can still join if you have at least one of these weight‑related health conditions: high blood pressure (hypertension), abnormal blood fats (dyslipidemia), pre‑diabetes (higher than normal blood sugar but not diabetes), obstructive sleep apnea (OSA) (a condition where breathing stops briefly during sleep), coronary artery disease (CAD) (narrowing of the heart’s blood vessels), heart failure (the heart cannot pump blood well), or cerebrovascular disease (problems with the blood vessels in the brain).
  • You must have tried at least one diet on your own and not been able to lose weight successfully.
  • Both men and women are allowed to take part in the study.
  • The study may have other specific requirements that are written in the detailed study plan (the protocol).

Who cannot join the trial?

6 criteria

  • Have a diagnosis of diabetes (both Type 1 and Type 2) or a blood test called HbA1c that is 6.5% or higher (HbA1c measures average blood sugar over several months).
  • Lost or gained more than 5 kg (about 11 lb) in the 90 days before the study starts.
  • Are currently using or have used in the past 90 days medicines that act on the GLP‑1‑RA pathway (drugs that affect a hormone involved in blood sugar and weight control) or any similar hormone‑based weight‑control therapy.
  • Are taking, or have taken in the past 90 days, any medicine that is intended to cause weight loss or weight gain, or are likely to start such a medicine during the study.
  • Have had, or plan to have, bariatric surgery (weight‑loss surgery).
  • Any other reasons listed in the study protocol as additional exclusion criteria.
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Investigated drugs

Olatorepatide is a medicine that works by activating two hormones called GLP‑1 and GIP, which help control appetite and metabolism. In this study, it is given as a liquid that is injected under the skin. The trial is testing whether Olatorepatide can help people who are overweight or have obesity lose weight, and it is also looking at how safe the medicine is for participants who do not have diabetes.

What is already known about the treatment

Olatorepatide - Olatorepatide is given as a liquid that is injected under the skin (subcutaneous injection). It is still an investigational drug being studied in Phase 3 trials and is not yet approved for general medical use. The medicine is being tested to help people who are overweight or have obesity but do not have diabetes, aiming to reduce body weight. It works by activating the GLP‑1 and GIP receptors, which helps control appetite and improves how the body handles sugar, and it is classified as a GLP‑1/GIP receptor agonist peptide.

Investigated diseases

Overweight or Obesity Without Diabetes - Overweight or obesity without diabetes is a condition where a person carries excess body weight, measured by body‑mass index, but does not have diabetes. It results from a long‑term imbalance between calories consumed and calories burned, causing fat to build up under the skin and around organs. The excess weight often starts in the abdominal area and can spread to other parts of the body. As the condition persists, the amount of stored fat may increase, moving the individual into higher weight‑category ranges. This gradual increase can affect how the body uses energy and may place additional strain on the cardiovascular and musculoskeletal systems.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524861-26-00Protocol codeHS-20094-OB-2570Estimated enrolment2 838 patientsSponsorRegeneron Pharmaceuticals Inc.

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