In short
Olatorepatide is an investigational medicine being studied in overweight and obesity, with and without type 2 diabetes. It is a GLP-1/GIP receptor agonist, a class of drugs that acts on gut hormones involved in appetite and metabolism. Two Phase 3 trials have been registered, one with 1,500 planned participants and one with 3,000. A Phase 2 trial in hidradenitis suppurativa with overweight or obesity has also been reported.
Key points
- Olatorepatide is an investigational substance not yet authorised as a medicine.
- It is a GLP-1/GIP receptor agonist, a dual gut-hormone receptor activator.
- Two registered Phase 3 trials study it in overweight or obesity, one with and one without type 2 diabetes.
- The trials planned to enrol 1,500 and 3,000 participants, respectively, and measure percent change in body weight.
- One of the Phase 3 trials has been withdrawn; the other is authorised.
- A Phase 2 trial is planned in moderate to severe hidradenitis suppurativa in people with overweight or obesity.
What is olatorepatide?
Olatorepatide is an investigational substance, meaning it has not been authorised as a medicine and is still being studied in clinical trials. It belongs to a class of drugs known as GLP-1/GIP receptor agonists. These are dual activators of two gut-hormone receptors, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). The full name olatorepatide is used once here; the short label olatorepatide is used throughout the rest of this page. The substance is given by subcutaneous injection in the registered trials.
How does olatorepatide work?
Olatorepatide activates the GLP-1 and GIP receptors. These receptors are part of the body's system that controls appetite, food intake and the way the body handles sugar and energy. Activating both receptors is intended to reduce body weight. In the registered trials, the main measure is the percent change in body weight from the start of the study. The Phase 2 trial profile describes olatorepatide as a GLP-1/GIP receptor agonist studied in hidradenitis suppurativa in people living with overweight or obesity.
Which conditions is olatorepatide studied for?
- Overweight or obesity with type 2 diabetes — one Phase 3 trial was planned in adults with this combination of conditions.
- Overweight or obesity without diabetes — a separate Phase 3 trial is authorised in adults with overweight or obesity and no diabetes.
- Hidradenitis suppurativa — a Phase 2 trial is planned in adults with moderate to severe hidradenitis suppurativa who also live with overweight or obesity.
How is olatorepatide given?
In the registered trials, olatorepatide is given as a subcutaneous injection, which means an injection under the skin. The trial records list the dose as 00 mg, meaning the dose was not reported in the register. The placebo used for comparison is also given by subcutaneous injection.
What do the clinical trials show?
Two Phase 3 trials of olatorepatide are registered in the EU Clinical Trials Information System. One trial, in adults with overweight or obesity and type 2 diabetes, planned to enrol 1,500 participants and has been withdrawn. The other, in adults with overweight or obesity without diabetes, planned to enrol 3,000 participants and is authorised. Both trials are interventional studies with the same primary outcome: percent change in body weight. The stated aim is to demonstrate that olatorepatide is superior to placebo as measured by body weight loss.
A Phase 2 trial is also reported in a separate registry profile. It is a randomised, double-blind, placebo-controlled, parallel-group 52-week trial in adults with moderate to severe hidradenitis suppurativa living with overweight or obesity. Its status is not yet recruiting.
Because the Phase 3 trials have not reported results — one is withdrawn and the other has not published findings on this page — no efficacy results are available here. The trials measure body weight change over time, and the Phase 2 trial is designed to run for 52 weeks.
What side effects are known?
The sources provided do not report side effects of olatorepatide. No side effect information is available on this page.