A Phase 2 interventional study of Tirzepatide and Placebo in Long COVID, sponsored by Scripps Translational Science Institute. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by Scripps Translational Science Institute · Phase 2, Interventional, and Treatment
The goal of this study is to determine whether a medicine called tirzepatide, also called Zepbound, can reduce symptoms of Long COVID. A randomized control trial will allow us to measure the effect of the treatment by having half of the participants take the medication and half take a placebo that has no medication. Participants will take the medication (or placebo) they are given and complete study surveys for 12 months. All of the study tasks are done remotely from the comfort of a participants home.
520 studies on the registry are indexed under Post-Acute COVID-19 Syndrome; 186 are open to participants now.
This study's enrollment of 1,000 is above the median of 60 across 361 interventional studies indexed under Post-Acute COVID-19 Syndrome.
Browse Post-Acute COVID-19 Syndrome studies →Scripps Translational Science Institute is the lead sponsor of 52 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Ability to verify identity Ability to verify diagnosis Agree to notify the study team if you start any other Long COVID treatments while enrolled in the study.
Complete the Fatigue Severity Scale with a minimum score of 36
Exclusion Criteria:
Drug: Placebo
Drug: Tirzepatide
The treatment group will receive the study medication (tirzepatide) for a 12 month period starting with a 2.5mg dose once a week.
Participants in the control group will receive a placebo instead of active study medication for a 12 month period.
Primary Objective 1: Changes in fatigue severity score, measured by Fatigue Severity Scale (FSS)
The average difference in Fatigue Severity Scale (minimum score 9, maximum score 63, with higher scores indicating worse fatigue) between treatment and control groups of adults with Long COVID at month 3 or month 12 after study start
Time frame: 12 months
Secondary Outcome: Changes in overall health, measured by European Quality of Life 5 day, 5 level (EQ-5D-5L) scores
EQ-5D-5L is a quality of life survey with a minimum score of 5 and a maximum score of 25, with a higher score indicating worse quality of life.
Time frame: 12 months
Secondary Outcome: Presence of and changes in post-exertional malaise, a condition that occurs in subsets of Long COVID and IACIs, measured by DePaul Symptom Questionnaire Post Exertional Malaise (DSQ-PEM)
DSQ-PEM evaluates the presence or absence of PEM and myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS)
Time frame: 12 month
Secondary Outcome: Changes in functional capacity as measured by Functional Capacity (FUNCAP) survey
The 27-question version of FUNCAP has a minimum score of 0 and a maximum score of 162, with a lower score indicating lower functional capacity.
Time frame: 12 months
Plan to share: No — The investigators may share the coded study data with researchers outside of Scripps Research. Before doing so, they will ensure that nothing in the data can identify the participant directly.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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