Not Authorised Therapeutic confirmatory (Phase III) Overweight or Obesity with Type 2 Diabetes.

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

EU CTIS ID: 2025-524860-39-00

What this study is testing

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Have Body Mass index (BMI) ≥27.0 kg/m^2 at screening.
  • Diagnosis of type 2 diabetes (T2D) at least 90 days prior to screening as described in the protocol.
  • T2D treated with standard diet and exercise regimen with 0–3 oral Glucose Lowering Medications (GLMs) as described in the protocol
  • History of one or more self-reported unsuccessful dietary attempts to lose weight.
  • Other Protocol Defined Inclusion Criteria Apply.

You likely can't join if

  • Have previous or current diagnosis Type 1 diabetes (T1D) or any other type of diabetes except T2D as described in the protocol.
  • Change in body weight >5 kg within 90 days prior to randomization as described in the protocol.
  • Current or previous treatment within 90 days prior to screening visit with Dipeptidyl Peptidase-4 (DPP-4) inhibitors, GLP-1 RA, GLP-1/GIP RA, related molecule, any Nutrient-Stimulated Hormone (NuSH) -based therapy, or any injectable therapy for T2D as described in the protocol.
  • Has a history of: Proliferative diabetic retinopathy or diabetic maculopathy, non-proliferative diabetic retinopathy that is being actively treated, history of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) as described in the protocol.
  • Current treatment or treatment within 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.
See the full eligibility criteria
Who can join
  • Have Body Mass index (BMI) ≥27.0 kg/m^2 at screening.
  • Diagnosis of type 2 diabetes (T2D) at least 90 days prior to screening as described in the protocol.
  • T2D treated with standard diet and exercise regimen with 0–3 oral Glucose Lowering Medications (GLMs) as described in the protocol
  • History of one or more self-reported unsuccessful dietary attempts to lose weight.
  • Other Protocol Defined Inclusion Criteria Apply.
What rules you out
  • Have previous or current diagnosis Type 1 diabetes (T1D) or any other type of diabetes except T2D as described in the protocol.
  • Change in body weight >5 kg within 90 days prior to randomization as described in the protocol.
  • Current or previous treatment within 90 days prior to screening visit with Dipeptidyl Peptidase-4 (DPP-4) inhibitors, GLP-1 RA, GLP-1/GIP RA, related molecule, any Nutrient-Stimulated Hormone (NuSH) -based therapy, or any injectable therapy for T2D as described in the protocol.
  • Has a history of: Proliferative diabetic retinopathy or diabetic maculopathy, non-proliferative diabetic retinopathy that is being actively treated, history of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) as described in the protocol.
  • Current treatment or treatment within 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.
  • Other Protocol Defined Exclusion Criteria Apply.

The study team makes the final eligibility decision.

Where it's taking place

  • Canada
  • Mexico
  • United Kingdom
  • United States
  • Puerto Rico
  • Australia

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Canada; Mexico; United Kingdom; United States; Puerto Rico; Australia. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.