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Petrelintide

A new clinical trial is underway to investigate the effectiveness of Petrelintide, a long-acting amylin analog, in managing weight for individuals with obesity or those who are overweight with related health issues. This study aims to compare different doses of Petrelintide against a placebo to determine its impact on body weight, safety, and how well it’s tolerated by participants.

Table of Contents

What is Petrelintide?

Petrelintide, also known by its experimental name ZP8396, is a new medication being developed to help manage weight in people with obesity or those who are overweight with related health problems[1]. It’s designed as a long-acting amylin analog, which means it mimics the effects of a hormone called amylin that plays a role in regulating appetite and metabolism[1].

How Does Petrelintide Work?

While the exact mechanism isn’t fully detailed in the clinical trial information, as an amylin analog, Petrelintide likely works by:

  • Helping to control appetite and reduce food intake
  • Slowing down the emptying of the stomach, which can make you feel full for longer
  • Potentially affecting metabolism and how the body processes nutrients
These effects, combined with a reduced-calorie diet and increased physical activity, are intended to help patients lose weight and improve their overall health[1].

Clinical Trial Details

Petrelintide is currently being studied in a Phase 2 clinical trial. Here are some key details about the study[1]:

  • It’s a randomized, double-blind, placebo-controlled trial. This means participants are randomly assigned to either receive Petrelintide or a placebo, and neither the participants nor the researchers know who is getting which treatment during the study.
  • The trial is testing five different doses of Petrelintide against a placebo.
  • The study lasts for about a year, divided into three periods:
    1. A 2-3 week screening period
    2. A 42-week treatment period
    3. A 9-week safety follow-up period

Potential Benefits of Petrelintide

The clinical trial is designed to measure several potential benefits of Petrelintide[1]:

  • Weight loss: The primary goal is to see how much weight people lose compared to their starting weight after 28 weeks of treatment.
  • Sustained weight loss: The study will also look at weight loss after 42 weeks to see if the effects are maintained.
  • Waist circumference reduction: This can be an important indicator of health, especially related to abdominal fat.
  • Improvements in blood sugar control: The study will measure changes in HbA1c (a long-term measure of blood sugar levels) and fasting glucose.
  • Reduction in inflammation: Measured by changes in high-sensitivity C-reactive protein (hsCRP), a marker of inflammation in the body.
  • Improvements in blood lipids: This includes measures of cholesterol and other fats in the blood.

Administration and Dosage

Petrelintide is designed to be taken once a week as a subcutaneous injection. This means it’s injected just under the skin, similar to how some diabetes medications are given. Patients in the trial will be taught to self-administer these injections[1].

Safety and Side Effects

As with any new medication, monitoring for safety and side effects is a crucial part of the clinical trial. The study will track[1]:

  • Treatment emergent adverse events (TEAEs): These are any new medical problems or worsening of existing problems that occur during the trial.
  • Anti-drug antibodies (ADAs): The body’s immune system might produce antibodies against Petrelintide, which could affect its effectiveness or safety. The study will monitor for this.
It’s important to note that as this is an ongoing clinical trial, the full safety profile and potential side effects of Petrelintide are not yet known.

Aspect Details
Drug Name Petrelintide (also known as ZP8396)
Purpose Weight management for obesity or overweight individuals with related health issues
Administration Once-weekly subcutaneous self-injection
Study Design Randomized, double-blind, placebo-controlled, Phase 2 clinical trial
Duration 54 weeks (including 42-week treatment period)
Primary Outcome Percent change in body weight from baseline to Week 28
Secondary Outcomes Changes in body weight, waist circumference, HbA1c, fasting glucose, hsCRP, and fasting lipids; percentage of participants achieving ≥5% and ≥10% weight loss
Safety Assessments Treatment emergent adverse events (TEAEs) and anti-drug antibodies (ADAs)

FAQ

  • What is Petrelintide and how is it administered? Petrelintide is a long-acting amylin analog being developed for weight management. In this trial, it's administered as a once-weekly self-injection under the skin (subcutaneously).
  • How long does the clinical trial last? The trial consists of three periods: a 2-3 week screening period, a 42-week treatment period, and a 9-week safety follow-up period, totaling about 54 weeks.
  • What are the main goals of this Petrelintide study? The main goals are to compare different doses of Petrelintide against a placebo to see how it affects body weight, to assess its safety, and to determine how well participants tolerate the treatment.
  • What measurements will be taken during the trial? The study will measure changes in body weight, waist circumference, blood sugar levels (HbA1c and fasting glucose), inflammation markers (hsCRP), and blood fats (lipids). It will also track any side effects and the development of antibodies against the drug.
  • Who can participate in this clinical trial? The trial is designed for individuals with obesity or those who are overweight with weight-related health issues. Specific eligibility criteria would be provided by the study coordinators.

Ongoing Clinical Trials on Petrelintide

  • Study on Petrelintide for Weight Loss in Overweight or Obese Patients with Related Health Issues

    Not recruiting

    1
    Investigated drugs:
    Poland Romania

Glossary

  • Amylin analog: A synthetic version of the hormone amylin, which helps regulate blood sugar levels and feelings of fullness after eating.
  • Subcutaneous injection: A method of administering medication by injecting it into the layer of fat just beneath the skin.
  • Placebo: A substance with no active medical benefits, used as a control in testing new drugs.
  • Randomized, double-blind study: A type of clinical trial where participants are randomly assigned to different treatment groups, and neither the participants nor the researchers know who is receiving which treatment.
  • Hemoglobin A1c (HbA1c): A blood test that measures average blood sugar levels over the past 2-3 months.
  • High-sensitivity C-reactive protein (hsCRP): A blood test that measures low levels of inflammation in the body.
  • Fasting lipids: Blood tests that measure various types of fats in the blood, such as cholesterol and triglycerides, after a period of not eating.
  • Anti-drug antibodies (ADAs): Proteins produced by the immune system in response to a medication, which can potentially reduce the drug's effectiveness or cause side effects.
  • Treatment emergent adverse events (TEAEs): Any unfavorable medical occurrence that appears or worsens after starting a medical treatment.

References

  1. https://clinicaltrials.gov/study/NCT06662539