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Efficacy and Safety of Olatorepatide in Adults with Overweight or Obesity and Type 2 Diabetes

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What is this trial about?

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

The study focuses on adults who have overweight or obesity together with type 2 diabetes. These conditions mean that a person carries excess body weight and has difficulty controlling blood sugar levels. The investigational medicine is called olatorepatide, which is described as a GLP-1/GIP receptor agonist. This type of medicine works by helping the body use insulin better and can also reduce appetite, which may lead to weight loss. The drug is given as a small injection under the skin.

The purpose of the trial is to determine whether olatorepatide leads to greater weight loss than placebo. Participants will be randomly assigned to receive either the study medicine or a placebo injection and will be followed for several months. During the study they will have regular check‑ups to measure their body weight, blood sugar control using HbA1c (a lab test that shows average blood sugar over the past few months) and fasting plasma glucose (blood sugar after an overnight fast), and other health markers such as homeostatic model assessment for insulin resistance, systolic blood pressure, diastolic blood pressure, cholesterol numbers including LDL‑C, HDL‑C and VLDL‑C, inflammation measured by hs‑CRP, and kidney function using uACR. Safety will be monitored by checking for any anti‑drug antibody or neutralizing antibody responses and for any treatment‑emergent adverse events that may occur.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessment

    After enrollment, you will attend a baseline visit where your weight, height, blood pressure, and blood samples will be measured. these measurements establish the starting point for the study.

    The study staff will also review your medical history and current medications to confirm eligibility.

  2. Step 2

    Randomization

    Following the baseline assessment, you will be randomly assigned to receive either olaterepatide or a matching placebo. the assignment is concealed, so you will not know which product you receive.

  3. Step 3

    Medication administration

    You will receive a subcutaneous injection (injection under the skin) of the study medication. the injection is a solution for injection that is prepared by the study staff.

    The dose amount is defined by the study protocol and will be administered according to the schedule set by the study team. the frequency (for example, once weekly) and total duration of treatment will be explained at the visit.

  4. Step 4

    Regular follow‑up visits

    Throughout the treatment period, you will return to the clinic at regular intervals (for example, every four weeks) for follow‑up visits.

    During each visit, your weight, waist circumference, blood pressure, and blood samples (including glucose, hemoglobin a1c, cholesterol, and other labs) will be measured to track changes.

    The study staff will also check the injection site and record any side effects.

  5. Step 5

    Safety monitoring

    At every visit you will be asked about any new symptoms or problems you have experienced since the previous visit.

    Any treatment‑emergent adverse events (new or worsening health issues) will be documented and evaluated by the study team.

  6. Step 6

    Final visit and end of treatment

    At the end of the study period, you will attend a final visit where the same measurements taken at baseline will be repeated.

    The study medication will be stopped, and you will receive instructions about any further care or monitoring that may be needed.

  7. Step 7

    Post‑study follow‑up

    After the final visit, the study may schedule a short follow‑up contact to check for any late‑appearing side effects. participation in this follow‑up is optional.

Who can join the trial?

5 criteria

  • You must have a Body Mass Index (BMI) of 27 or higher when you are screened. BMI is a number that compares your weight to your height to see if you are in a healthy range.
  • You must have been diagnosed with type 2 diabetes (T2D) at least 90 days before the screening. Type 2 diabetes is a condition where the body has trouble controlling blood sugar levels.
  • Your diabetes must be managed with a regular diet and exercise plan, and you may be taking up to three oral medicines that lower blood sugar, called oral glucose‑lowering medications.
  • You must have tried at least one diet on your own that did not help you lose weight.
  • You must also meet any other requirements that are listed in the study’s detailed protocol.

Who cannot join the trial?

7 criteria

  • You cannot have a previous or current diagnosis of Type 1 diabetes (a form of diabetes where the body does not produce insulin) or any other type of diabetes besides Type 2 diabetes.
  • You must not have gained or lost more than 5 kilograms (about 11 pounds) in the 90 days (roughly three months) before you are randomly assigned to a study group.
  • You cannot have taken, in the 90 days before screening, any of the following diabetes medicines: DPP‑4 inhibitors (a class that helps control blood sugar), GLP‑1 receptor agonists (GLP‑1 RA) or GLP‑1/GIP receptor agonists (drugs that mimic natural hormones to lower blood sugar), any medication based on nutrient‑stimulated hormones (NuSH), or any injectable therapy for diabetes.
  • You must not have a history of serious eye problems caused by diabetes, such as proliferative diabetic retinopathy (advanced damage to the retina), diabetic maculopathy (damage to the central part of the retina), actively treated non‑proliferative diabetic retinopathy, or a condition called Non‑arteritic Anterior Ischemic Optic Neuropathy (NAION) (sudden vision loss due to reduced blood flow to the optic nerve).
  • You cannot be using, or have used in the past 90 days, any medication or program that is intended to cause weight loss or weight gain, or that has a high chance of being started during the study.
  • You must not have had, and you cannot be planning to have, bariatric surgery (weight‑loss surgery).
  • Other reasons defined by the study protocol may also make you ineligible to participate.
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Investigated drugs

Olatorepatide
Olatorepatide is a medication that works by activating the GLP‑1 and GIP receptors in the body. It is given as a solution that is injected under the skin. In this study, the drug is being tested to see if it can help people who are overweight or obese and have type 2 diabetes lose weight. Researchers are looking at how well it works and whether it is safe compared to a placebo.

What is already known about the treatment

Olatorepatide - Olatorepatide is given as a clear solution for subcutaneous injection, meaning it is injected under the skin. It is currently an investigational drug being studied in Phase 3 trials for safety and effectiveness. The medication is aimed at people who are overweight or have obesity together with type 2 diabetes, helping them lose weight and improve blood sugar control. It works by activating both GLP‑1 and GIP receptors, which boosts insulin release, lowers appetite, and slows stomach emptying, classifying it as a dual GLP‑1/GIP receptor agonist peptide.

Investigated diseases

Obesity with type 2 diabetes - This condition combines excess body weight with impaired blood‑sugar regulation characteristic of type 2 diabetes. The extra fat, especially around the abdomen, increases the body’s resistance to insulin, making glucose control harder. As insulin resistance grows, blood‑sugar levels tend to rise, prompting the pancreas to produce more insulin. Over time, the combined metabolic stress can lead to higher blood pressure and changes in cholesterol levels. Without changes in diet, activity, or other factors, both weight and blood‑sugar measures usually worsen gradually.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524860-39-00Protocol codeHS-20094-OB-2584Estimated enrolment1 500 patientsSponsorRegeneron Pharmaceuticals Inc.

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