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GLP-1 Receptor Agonist
Retatrutide for Type 2 Diabetes and Obesity (TRIUMPH-2 Trial)
Verified 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
Have a body mass index (BMI) greater than or equal to 27.0 kilogram/square meter (kg/m ²)
Have Type 2 Diabetes (T2D)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 80
Awards & highlights
TRIUMPH-2 Trial Summary
This trial evaluates the safety and effectiveness of a treatment for type 2 diabetes in people with obesity/overweight, inc. those with OSA. The study lasts 89 weeks and 24 visits.
Who is the study for?
This trial is for adults with Type 2 Diabetes and a BMI of at least 27, who have tried to lose weight unsuccessfully. Participants may also have moderate-to-severe obstructive sleep apnea (OSA) but should not be on certain OSA treatments or recent weight loss drugs. They mustn't have had significant weight changes recently or any history of specific thyroid cancers.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of Retatrutide in people with Type 2 Diabetes who are overweight or obese, including some with OSA. It's an approximately 89-week study involving up to 24 visits, comparing Retatrutide against a placebo.See study design
What are the potential side effects?
While the side effects for Retatrutide aren't specified here, common side effects for diabetes medications can include nausea, vomiting, digestive issues, potential low blood sugar events, and sometimes injection site reactions.
TRIUMPH-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have a body mass index (BMI) of 27.0 or higher.
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I have Type 2 Diabetes.
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I have been on a stable treatment for type 2 diabetes for at least 3 months.
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I have been diagnosed with obstructive sleep apnea.
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You have a score of 15 or higher on a sleep test, which means you have moderate-to-severe obstructive sleep apnea.
Select...
I have used PAP therapy for 3 months and can stop it for 7 days before sleep studies.
TRIUMPH-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 80
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 80
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 Apnea-Hypopnea Index (AHI) for GSA2 Subset
Percent Change from Baseline in Body Weight
Secondary outcome measures
A Hierarchical Combination of Functional Outcomes of Sleep Questionnaire (FOSQ) 10 score, FOSQ Vigilance Domain Score, and FOSQ Activity Level Domain Score for GSA2 Subset
Change from Baseline in Body Mass Index (BMI)
Change from Baseline in Diastolic Blood Pressure (DBP)
+11 moreTRIUMPH-2 Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Retatrutide Dose 3Experimental Treatment1 Intervention
Participants will receive retatrutide SC.
Group II: Retatrutide Dose 2Experimental Treatment1 Intervention
Participants will receive retatrutide SC.
Group III: Retatrutide Dose 1Experimental Treatment1 Intervention
Participants will receive retatrutide subcutaneously (SC).
Group IV: 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
3,215,599 Total Patients Enrolled
55 Trials studying Obesity
50,219 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
1,348 Previous Clinical Trials
414,745 Total Patients Enrolled
38 Trials studying Obesity
29,938 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had pancreatitis.You have a moderate-to-severe obstructive sleep apnea, which is confirmed by a specific test called polysomnography.I have used PAP therapy for 3 months and can stop it for 7 days before sleep studies.You have tried to lose weight by changing your diet before, but it didn't work.I have been diagnosed with obstructive sleep apnea.I have been diagnosed with obstructive sleep apnea.You weigh more than what is considered healthy for your height.I have Type 2 Diabetes.I have Type 2 Diabetes.I haven't used stimulants like modafinil or amphetamines in the last 3 months.I have been on a stable treatment for type 2 diabetes for at least 3 months.I have lost or gained more than 11 pounds in the last 3 months.You have Type 1 diabetes.I have used weight loss drugs in the last 90 days.I or my family have a history of MTC or MEN-2.You have a score of 15 or higher on a sleep test, which means you have moderate-to-severe obstructive sleep apnea.I have had or am planning to have surgery for weight loss.I have been using PAP therapy for 3 months and can stop it for about a week for sleep studies.I have been diagnosed with obstructive sleep apnea.I haven't used certain sleep or pain medications in the last 3 months.I have Type 2 Diabetes.You have moderate-to-severe obstructive sleep apnea, which is diagnosed using a test called polysomnography and shows that you stop breathing or have shallow breathing 15 times or more in an hour while sleeping.You have a body mass index (BMI) of 27.0 or higher.You use a dental appliance or other device to treat obstructive sleep apnea, not including PAP therapy.I have Type 2 Diabetes.You have tried and failed to lose weight through dieting at least once.You have moderate-to-severe obstructive sleep apnea, as shown by a test called polysomnography.Your body mass index (BMI) is 27.0 or higher.You have a body mass index (BMI) of 27.0 or higher.I have Type 2 Diabetes.You have tried and failed to lose weight by changing your diet at least once.I have been diagnosed with obstructive sleep apnea.You have a score of 15 or more on a sleep test, which shows that you have moderate-to-severe obstructive sleep apnea.Your body mass index (BMI) is 27.0 or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Retatrutide Dose 1
- Group 2: Retatrutide Dose 2
- Group 3: Retatrutide Dose 3
- Group 4: Placebo
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.
Obesity Patient Testimony for trial: Trial Name: NCT05929079 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Retatrutide Dose 1 a safe option for those undergoing treatment?
"As it is a Phase 3 trial, there is ample data affirming the efficacy and safety of Retatrutide Dose 1. Thus, our team has rated its security at a full 3/3 on the scale."
Answered by AI
In what capacity are locations participating in this investigation?
"Valley Clinical Trials, Inc. in Northridge, Diablo Clinical Research, Inc. in Walnut Creek and Chase Medical Research LLC in Waterbury are three of the 92 trial sites that have been recruited for this study."
Answered by AI
Are there presently any available enrollments into this investigation?
"According to clinicaltrials.gov, this medical research is not currently recruiting patients as the listing was last updated on June 26th 2023. Nonetheless, there are a plethora of other trials that need volunteers and can be found using the same platform."
Answered by AI
Who else is applying?
What state do they live in?
South Carolina
Ohio
Missouri
Other
What site did they apply to?
Las Vegas Medical Research
Renstar Medical Research
National Research Institute - Wilshire
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
0
Why did patients apply to this trial?
Pro varios y no funcionan. To get healthier and lose weight. I want to lose weight and get healthier.
PatientReceived no prior treatments
I'm currently using a GLP-1 and it's not working. I need help. I haven’t tried drugs to lose weight. I would like to try your study.?
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
Is this trial located on 81st Avenue in Myrtle Beach?
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Average response time
- < 1 Day
Most responsive sites:
- Las Vegas Medical Research: < 24 hours
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