Your session is about to expire
← Back to Search
Other
Retatrutide for Obesity (TRIUMPH-4 Trial)
Phase 3
Recruiting
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 baseline, week 68
Awards & highlights
TRIUMPH-4 Trial Summary
This trial will study the safety and effectiveness of a once-weekly medication for people with obesity/overweight and knee osteoarthritis. It will last 77 weeks.
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.Check my eligibility
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.See study design
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.
TRIUMPH-4 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 68
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 68
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
Percent Change from Baseline in Body Weight
Secondary outcome measures
Change from Baseline in Average Pain Intensity Numeric Rating Score (API-NRS) Score
Change from Baseline in Body Mass Index (BMI)
Change from Baseline in Diastolic Blood Pressure (DBP)
+8 moreTRIUMPH-4 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.
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,620 Previous Clinical Trials
3,216,194 Total Patients Enrolled
24 Trials studying Osteoarthritis
4,975 Patients Enrolled for Osteoarthritis
Study DirectorEli Lilly and Company
1,348 Previous Clinical Trials
415,340 Total Patients Enrolled
9 Trials studying Osteoarthritis
1,888 Patients Enrolled for Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had steroid injections in my joints within the last 3 months.I have had joint injections or procedures in the last 6 months.I have a joint condition that is not osteoarthritis.I have used weight loss drugs in the last 90 days.I have had knee pain for more than 12 weeks and it hurt for over 15 days last month.I have been diagnosed with osteoarthritis according to ACR standards.I have diabetes.I have lost or gained more than 11 pounds in the last 3 months.I have had knee pain for more than 12 weeks and it has been painful for over 15 days in the last month.I have had or am planning to have surgery for weight loss.You have tried to lose weight through dieting in the past, but it didn't work for you.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Retatrutide Dose 1
- Group 3: Retatrutide Dose 2
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Food and Drug Administration approved Retatrutide Dose 1?
"Our team at Power placed Retatrutide Dose 1's safety score as a 3, given the substantial amount of clinical data that supports its efficacy and corroborates its security."
Answered by AI
Are there several locations in the city currently engaging with this research?
"This trial is currently running from 68 sites, with some of the more prominent ones being in San Diego, Waterbury and Miami. For those interested in participating it may be most convenient to select a clinic closest to them so as to reduce any potential travel burden."
Answered by AI
Are any new participants being accepted for this research endeavor?
"As evidenced on clinicaltrials.gov, this trial is not taking in patients at the moment; it was initially posted on August 7th 2023 and last updated June 27th of that year. Fortunately, there are over 1800 other medical studies actively recruiting participants right now."
Answered by AI
Who else is applying?
What site did they apply to?
Chase Medical Research, LLC
Arizona Research Center
Mercy Family Clinic
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
Low carb, calorie and phentermine. I to lose the weight can’t afford conventional medicines for diabetes, weight loss.
PatientReceived no prior treatments
I have tried a number of weight loss programs and hope to lose weight to relieve the stress on my joints.
PatientReceived 1 prior treatment
I've tried a few other medications and processes that didn't work. Plus, my insurance wouldn't pay for some of the medications. Thought maybe this trial would help.
PatientReceived no prior treatments
I need help, and I'm to the point now where I'm back in the wheelchair. I have Psoriatic arthritis I know I have arthritis in my knees so I hope I can be helpful to the study.
PatientReceived 2+ prior treatments
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger