What side effects are associated with this type of intervention?

Common treatments for osteoarthritis include weight reduction and anti-inflammatory medications. Weight reduction, achieved through lifestyle changes or medications, can lead to side effects such as gastrointestinal issues, nutrient deficiencies, and potential cardiovascular risks. Nonsteroidal anti-inflammatory drugs (NSAIDs), frequently used for their anti-inflammatory effects, are associated with gastrointestinal complications (e.g., ulcers, bleeding), cardiovascular risks (e.g., hypertension, myocardial infarction), and renal issues. Patients should discuss these potential side effects with their healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of osteoarthritis, focusing on both weight reduction and anti-inflammatory effects. For weight reduction, GLP-1 receptor agonists like liraglutide and semaglutide have been approved, which also show benefits in glycemic control and cardiovascular outcomes. For anti-inflammatory effects, NSAIDs such as naproxen, meloxicam, diclofenac, and ibuprofen are commonly used, although they come with potential cardiovascular and gastrointestinal risks. Additionally, intra-articular glucocorticoid injections are sometimes used for short-term pain relief in severe cases. However, newer investigational drugs like tanezumab, an anti-NGF agent, showed promise in pain reduction but were halted due to safety concerns, including rapidly progressive osteoarthritis.

What other types of research exist?

Promising novel alternatives to Retatrutide for osteoarthritis patients in 2024 include anti-TNF agents such as adalimumab and etanercept, IL-17 inhibitors like secukinumab and ixekizumab, and JAK inhibitors such as tofacitinib and upadacitinib. These treatments have shown efficacy in reducing inflammation and may provide additional benefits for weight management and osteoarthritis symptoms.

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Other

Retatrutide for Obesity (TRIUMPH-4 Trial)

Phase 3

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial is testing a weekly medication called retatrutide. It aims to help people who are overweight or obese and have knee osteoarthritis. The study will last over a year to see if the medication is safe and effective.

Who is the study for?

This trial is for adults who have been unsuccessful in past dieting efforts, are overweight or obese with a BMI ≥27, and suffer from knee pain due to osteoarthritis. They must not have used weight loss drugs recently, had certain joint procedures within the last 6 months, plan surgical treatments for obesity, have diabetes or other joint diseases besides OA.

What is being tested?

The study tests Retatrutide (LY3437943), given once weekly against a placebo to see if it's safe and effective for those with obesity/overweight and knee osteoarthritis. The trial will monitor participants over approximately 77 weeks.

What are the potential side effects?

While specific side effects of Retatrutide aren't listed here, common ones may include injection site reactions, gastrointestinal issues like nausea or diarrhea, potential allergic reactions, and changes in blood sugar levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Retatrutide Dose 2Experimental Treatment1 Intervention

Participants will receive retatrutide SC.

Group II: Retatrutide Dose 1Experimental Treatment1 Intervention

Participants will receive retatrutide subcutaneously (SC).

Group III: PlaceboPlacebo Group1 Intervention

Participants will receive placebo.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Osteoarthritis (OA) primarily aim to reduce pain and inflammation. Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen inhibit cyclooxygenase enzymes (COX-1 and COX-2), reducing the production of pro-inflammatory prostaglandins. Glucocorticoids, such as prednisone, decrease inflammation by suppressing multiple inflammatory pathways. Investigational treatments like anti-IL-1 blockade target specific inflammatory cytokines involved in OA pathogenesis. Weight reduction, as studied with Retatrutide, can alleviate joint stress and potentially reduce inflammation, offering dual benefits for OA patients. These mechanisms are crucial as they address both symptomatic relief and underlying inflammatory processes, improving overall joint function and quality of life for OA patients.

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Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor

2,640 Previous Clinical Trials

3,221,239 Total Patients Enrolled

24 Trials studying Osteoarthritis

4,975 Patients Enrolled for Osteoarthritis

Study DirectorEli Lilly and Company

1,358 Previous Clinical Trials

417,685 Total Patients Enrolled

9 Trials studying Osteoarthritis

1,888 Patients Enrolled for Osteoarthritis

Media Library

Retatrutide (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05931367 — Phase 3

Osteoarthritis Research Study Groups: Placebo, Retatrutide Dose 1, Retatrutide Dose 2

Osteoarthritis Clinical Trial 2023: Retatrutide Highlights & Side Effects. Trial Name: NCT05931367 — Phase 3

Retatrutide (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05931367 — Phase 3

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