Study on the Effects of Retatrutide for Patients with Obesity, Overweight, or Knee Osteoarthritis

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What is this study about?

This clinical trial is focused on studying the effects of a treatment called Retatrutide on individuals who are either obese or overweight. The study also includes participants who have knee osteoarthritis, a condition that causes pain and stiffness in the knee joint. Retatrutide is administered as a solution for injection under the skin, and it is being tested to see how effective and safe it is for these conditions. The trial involves a comparison between Retatrutide and a placebo injection, which is a substance with no active medication.

The purpose of the study is to evaluate how well Retatrutide works in helping participants lose weight and manage their knee osteoarthritis symptoms. Participants will receive weekly injections and will be monitored throughout the study to assess changes in their body weight and knee pain. The study is designed to be double-blind, meaning neither the participants nor the researchers know who is receiving the actual medication or the placebo, to ensure unbiased results.

Participants in the study will be those who have struggled with weight loss through diet alone and, for those with knee osteoarthritis, have experienced knee pain for more than 12 weeks. The study aims to provide valuable information on the potential benefits of Retatrutide for managing obesity, overweight, and knee osteoarthritis, contributing to better treatment options in the future.

1 initial assessment

The trial begins with an initial assessment to confirm eligibility. This includes verifying that the participant is overweight or has obesity, and for those in the knee osteoarthritis subset, confirming knee pain for more than 12 weeks and other specific symptoms.

2 randomization

Participants are randomly assigned to receive either the study medication, retatrutide, or a placebo. This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

3 treatment administration

The study medication, retatrutide, is administered as a solution for injection under the skin (subcutaneous injection).

The injections are given once a week. The exact dosage and duration of the treatment are determined by the study protocol.

4 monitoring and follow-up

Participants are regularly monitored to assess the efficacy and safety of the treatment. This includes measuring changes in body weight and, for those with knee osteoarthritis, changes in knee pain using a specific pain scale.

Regular follow-up visits are scheduled to track progress and any side effects.

5 completion of trial

The trial is expected to conclude by November 10, 2025. At the end of the trial, final assessments are conducted to evaluate the overall outcomes of the treatment.

Who Can Join the Study?

  • Must be overweight. This means having more body weight than is considered healthy for your height.
  • Must have a history of trying to lose weight through diet but not being successful.
  • If you have knee osteoarthritis (a condition that affects the knee joint), you must have had knee pain for more than 12 weeks before the study starts.
  • If you have knee osteoarthritis, you must also meet at least one of the following conditions:
    • Be older than 50 years.
    • Experience morning stiffness in the knee that lasts less than 30 minutes.
    • Have crepitus in the knee, which is a crackling or grating sound or feeling in the joint.
  • Both men and women can participate.
  • Participants from vulnerable populations are also eligible.

Who Cannot Join the Study?

  • Participants who have a medical condition that is not stable or is not well-controlled.
  • Individuals with a history of severe allergic reactions to any medication.
  • People who have participated in another clinical trial within the last 30 days.
  • Women who are pregnant or breastfeeding.
  • Individuals with a history of substance abuse or addiction.
  • Participants with any other condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Gama Diamed S.R.L. Mangalia Romania
Hospital General Universitario De Valencia Valencia Spain
Regia Med Kft. Szekesfehervar Hungary
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Medifarma-98 Kft. Nyiregyhaza Hungary
Salvia Lekston I Madej Sp. J. Katowice Poland
Consultmed S.R.L. Iasi Romania
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
Clinica Korall S.R.L. Satu Mare Romania
Area Sanitaria De Ferrol Ferrol Spain
Cabinet Medical Dr Geru S.R.L. Timisoara Romania
Diamed Obesity S.R.L. Galati Romania
Ambulatorium Sp. z o.o. Elblag Poland
Centrum Medyczne Intercor Sp. z o.o. Bydgoszcz Poland
Terpa Sp. z o.o. sp.k. Lublin Poland
DRC Kft. Balatonfured Hungary
Diabdana S.R.L. Oradea Romania
University Of Szeged Szeged Hungary
University Of Debrecen Debrecen Hungary
ClinDiab Kft. Budapest Hungary
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p. Elblag Poland
Centermed Sp. z o.o. Lublin Poland
Centrum Zdrowia Metabolicznego Pawel Bogdanski Poznan Poland
Hightech Medical Services SRL Bucharest Romania
Samodzielny Publiczny Zakład Opieki Zdrowotnej Opolskie Centrum Onkologii im. prof. Tadeusza Koszar Małopolskie, Tarnów Poland
Mhfpmtgek Ixvhfvcldp Cbrntbvn Slzqarrm Sbj z olle Warsaw Poland
Mqedqez Stzudq Bacau Romania
Pwsdwotkzyw Allfi Sowvj Sibiu Romania
Ssiuebthjofrlog Pcprfeoi Lxriahsh Dvsyixuzcsurk Lqcdpmlh Crrjpxpg i Oofmgaqd Kielce Poland
Haxjtgvu Uuqdibejghmul Mtuqyjd Df Vfzemgpyxv Santander Spain
Cymtbeu Mymetvo Do Diwfkuksti Sq Tkqrllwxb Axmtnijul Nigzhv Slbkfe Brasov Romania
Caibwdv Bimyd Kbufhgjebrv Pxugjsai Scu z ofuy Gdansk Poland
Hvncfaej Vnwv djcnqvwp Barcelona Spain
Hzuxhsqm Umwjhasoxeyad dp A Cbooju A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Hungary Hungary
Not recruiting
15.07.2023
Poland Poland
Not recruiting
15.07.2023
Romania Romania
Not recruiting
15.07.2023
Spain Spain
Not recruiting
15.07.2023

Trial locations

Investigated drugs:

Retatrutide is a medication being studied for its effectiveness and safety in people who are either obese or overweight. The trial aims to see how well this medication works in helping with weight management. Additionally, the study includes participants who have knee osteoarthritis to understand if the medication can also benefit those with joint issues related to obesity or overweight.

Osteoarthritis, Knee – This is a degenerative joint disease that affects the knee, leading to the breakdown of cartilage. As the cartilage wears away, bones may rub against each other, causing pain and stiffness. Over time, the joint may lose its normal shape, and bone spurs may develop. The condition can result in decreased mobility and difficulty performing daily activities. Symptoms often worsen with activity and improve with rest. Swelling and a grating sensation in the knee may also occur.

Overweight – This condition is characterized by having more body weight than is considered healthy for a given height. It is often measured using the Body Mass Index (BMI), where a BMI between 25 and 29.9 is classified as overweight. Being overweight can lead to increased pressure on joints and may contribute to the development of other health issues. It is often associated with an imbalance between calories consumed and calories expended. The condition can affect energy levels and physical activity. It is a common condition that can be managed with lifestyle changes.

Obesity – This is a condition where excess body fat has accumulated to the extent that it may have a negative effect on health. It is typically defined by a Body Mass Index (BMI) of 30 or higher. Obesity can lead to increased risk of various health problems, including heart disease, diabetes, and joint issues. It often results from a combination of genetic, behavioral, and environmental factors. The condition can affect physical mobility and overall quality of life. Managing obesity often involves changes in diet and physical activity.

Trial ID:
2023-503657-35-00
Protocol code:
J1I-MC-GZBJ, -GOA1
Trial Phase:
Therapeutic confirmatory (Phase III)

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