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Tirzepatide for Psoriatic Arthritis

Hagerstown, MD
Phase 4
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
Must be able to initiate tirzepatide (Day 0) within 30 days of treatment decision (baseline or screening)
Have a diagnosis of active psoriatic arthritis (PsA) as defined by a rheumatologist or other healthcare professional (HCP) experienced in treating PsA
Must not have
Have a history of chronic or acute pancreatitis at any time before screening
Have a history of severe gastrointestinal complications, including gastroparesis, gastroesophageal reflux disease, dyspepsia, chronic nausea/vomiting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6 and month 12
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial aims to see if adding tirzepatide to ixekizumab treatment is helpful for people with moderate-to-severe Psoriatic Arthritis (PsA) who are also

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Who is the study for?
This trial is for people with active Psoriatic Arthritis (PsA) who are also overweight or obese and have at least one weight-related health issue. Participants should already be receiving ixekizumab therapy as part of their standard care.Check my eligibility
What is being tested?
The study tests the effectiveness of adding a medication called tirzepatide to existing ixekizumab treatment in patients with PsA and obesity over a period of up to 12 months, observing how well it works in regular clinical settings.See study design
What are the potential side effects?
Possible side effects of tirzepatide may include gastrointestinal symptoms like nausea, diarrhea, reduced appetite, vomiting, abdominal pain, fatigue, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can start tirzepatide within 30 days of deciding to treat.
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I have been diagnosed with active psoriatic arthritis by a specialist.
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My BMI is 30 or higher, or between 27 and 30 with a weight-related health issue.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had pancreatitis before.
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I have had severe stomach or digestion problems like gastroparesis or GERD.
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I have been on ixekizumab for either more than 4 months or less than 2 months.
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I have used medications like tirzepatide or other GLP-1 receptor agonists.
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I have been diagnosed with multiple endocrine neoplasia type 2.
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I have type 1 diabetes.
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I or my family have a history of medullary thyroid cancer.
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I have had ketoacidosis or a severe hyperglycemic state.
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I have a serious diabetic eye condition needing immediate treatment.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6 and month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 and month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy
Percentage of Participants Achieving at Least a 10% Weight Loss at 12 Months of Therapy
Secondary study objectives
Mean Percent Change of Weight from Baseline
Percentage of Participants Achieving Body Surface Area (BSA) ≤3%
Percentage of Participants Achieving HAQ-DI Sore ≤0.5 and at Least a 10% Weight Loss
+10 more

Side effects data

From 2022 Phase 3 trial • 210 Patients • NCT05024032
40%
Diarrhoea
30%
Nausea
27%
Decreased appetite
23%
Upper respiratory tract infection
19%
Abdominal distension
11%
Vomiting
11%
Gastroenteritis
9%
Flatulence
9%
Abortion induced
7%
Abdominal pain upper
7%
Gingivitis
7%
Amylase increased
7%
Lipase increased
6%
Abdominal pain
6%
Injection site reaction
6%
Menstruation irregular
4%
Hepatic function abnormal
4%
Hyperuricaemia
3%
Uterine polyp
3%
Vaginal infection
3%
Dizziness
1%
Hand fracture
1%
Supraventricular tachycardia
1%
Hiccups
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
10 mg Tirzepatide
15 mg Tirzepatide

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TirzepatideExperimental Treatment1 Intervention
Participants will continue on ixekizumab and take tirzepatide administered subcutaneously (SC) as per label.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
2019
Completed Phase 3
~7510

Find a Location

Closest Location:Klein & Associates, M.D., P.A.· Hagerstown, MD

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,696 Previous Clinical Trials
3,470,067 Total Patients Enrolled
7 Trials studying Psoriatic Arthritis
6,323 Patients Enrolled for Psoriatic Arthritis
Study DirectorEli Lilly and Company
1,398 Previous Clinical Trials
432,229 Total Patients Enrolled
5 Trials studying Psoriatic Arthritis
1,823 Patients Enrolled for Psoriatic Arthritis
~133 spots leftby Jan 2027
Unbiased ResultsWe believe in providing patients with all the options.
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