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Placebo
Tirzepatide for Weight Loss Maintenance in Obesity
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
Have a Body Mass Index (BMI) of ≥30 kilogram/square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least 1 of the following weight related comorbidities: Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 60, week 112
Awards & highlights
Study Summary
This trial looks at the effectiveness and safety of a drug to help people keep weight off.
Who is the study for?
This trial is for adults with obesity or overweight who have related health issues like high blood pressure, sleep apnea, or heart disease. They should have tried to lose weight before without success. People with severe depression, diabetes, recent major heart problems, significant weight changes in the last 3 months, pancreatitis, or a family history of certain thyroid cancers cannot join.Check my eligibility
What is being tested?
The study tests Tirzepatide's ability to help maintain weight loss compared to a placebo (a treatment with no active drug). Participants will be randomly assigned to receive either Tirzepatide or the placebo and monitored for effectiveness and safety.See study design
What are the potential side effects?
Possible side effects of Tirzepatide may include digestive issues such as nausea and diarrhea, potential low blood sugar levels especially if taking other diabetes medications concurrently, increased heart rate and allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is over 27 and I have a weight-related health issue like high blood pressure or heart disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 60, week 112
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 60, week 112
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent Maintenance of Body Weight (BW) Reduction Achieved during the 60-Week Weight Loss Period
Secondary outcome measures
Change from Randomization in Body Weight
Change from Randomization in Waist Circumference
Number of Participants with an Assessment of (yes/no) of Maintaining ≥ 15% BW Reduction for Participants Who Have Already Lost ≥15% BW at Randomization
+4 moreSide effects data
From 2022 Phase 3 trial • 210 Patients • NCT0502403240%
Diarrhoea
30%
Nausea
27%
Decreased appetite
23%
Upper respiratory tract infection
19%
Abdominal distension
11%
Gastroenteritis
11%
Vomiting
9%
Abortion induced
9%
Flatulence
7%
Abdominal pain upper
7%
Gingivitis
7%
Amylase increased
7%
Lipase increased
6%
Injection site reaction
6%
Menstruation irregular
6%
Abdominal pain
4%
Hepatic function abnormal
4%
Hyperuricaemia
3%
Uterine polyp
3%
Dizziness
3%
Vaginal infection
1%
Supraventricular tachycardia
1%
Hand fracture
1%
Hiccups
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 mg Tirzepatide
15 mg Tirzepatide
Placebo
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Tirzepatide Maximum Tolerated DoseExperimental Treatment1 Intervention
Participants will receive tirzepatide SC.
Group II: Tirzepatide 5 milligram (mg)Experimental Treatment1 Intervention
Participants will receive tirzepatide subcutaneously (SC).
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
2019
Completed Phase 3
~7590
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,613 Previous Clinical Trials
3,200,529 Total Patients Enrolled
53 Trials studying Obesity
40,428 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
404,852 Total Patients Enrolled
36 Trials studying Obesity
20,147 Patients Enrolled for Obesity
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How hazardous is the administration of Tirzepatide 5 mg to individuals?
"With a score of 3, Tirzepatide 5 milligram (mg) is believed to be relatively safe due to the prior clinical data seen in Phase 3 trials."
Answered by AI
Are there various facilities in this jurisdiction that are conducting the experimental research?
"A variety of clinical trial sites are open for enrollment, such as National Research Institute - Wilshire in Los Angeles, New Horizon Research Center in Miami and Southern California Dermatology Inc. in Santa Ana; there are an additional 20 locations available to participants."
Answered by AI
Is enrollment currently open for this experiment?
"Per the clinicaltrials.gov database, this medical research is no longer in search of enrollees. The study was added on September 29th 2023 and its last update took place on September 14th 2023. Despite that, there are still 1369 other trials actively seeking patients right now."
Answered by AI
Who else is applying?
What site did they apply to?
Alliance for Multispecialty Research, LLC
National Research Institute - Wilshire
Cahaba Research - Pelham
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
I am considered obese. I heard that tirzepatide works. having a hard time losing weight.
PatientReceived no prior treatments
I am interested in losing weight to improve A1C. I've tried Metformin, Phentermine and other with no luck.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
how long will the qualification time be?
PatientReceived 2+ prior treatments
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