Tirzepatide for Partial Lipodystrophy

(TILT-2024 Trial)

Overseen By Adam Neidert, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Michigan

Must not be taking: GLP-1 agonists, Tirzepatide, Metreleptin, others

Disqualifiers: Generalized lipodystrophy, Pancreatitis, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Tirzepatide, a medication, to determine if it can help individuals with partial lipodystrophy—a rare condition causing abnormal fat tissue loss—better manage diabetes and lower triglycerides, a type of fat in the blood. The study will investigate whether Tirzepatide can reduce calorie intake, potentially improving diabetes control and lowering blood fat levels. Individuals with familial partial lipodystrophy who struggle with diabetes management or have high triglycerides might be suitable candidates. As a Phase 2 trial, this research measures Tirzepatide's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant findings.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who have recently used certain medications like GLP-1 agonists, Tirzepatide, and some others. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that Tirzepatide is likely to be safe for humans?

Research has shown that Tirzepatide is generally safe for patients, with most side effects being mild and involving stomach issues, such as nausea or diarrhea. Serious problems are rare.

In earlier studies, patients taking Tirzepatide experienced significant health improvements. For example, one patient with very high triglyceride levels (a type of fat in the blood) saw a large decrease. This suggests the treatment is effective without causing serious harm.

Tirzepatide has already been approved for other conditions, which adds confidence about its safety. This approval indicates it has passed strict safety tests in humans. However, individual reactions may vary, so it is important to consult a healthcare professional with any concerns. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for partial lipodystrophy, which often focus on managing symptoms with medications like leptin analogs or lifestyle changes, Tirzepatide offers a novel approach by targeting GLP-1 and GIP receptors. This dual action can enhance insulin sensitivity and improve metabolic health, which is particularly beneficial for managing the complex symptoms of lipodystrophy. Researchers are excited about Tirzepatide because it could potentially address both glucose and lipid metabolism more effectively than current options, offering a more comprehensive treatment for individuals with this condition.

What evidence suggests that Tirzepatide might be an effective treatment for lipodystrophy?

This trial will evaluate Tirzepatide for partial lipodystrophy. Studies have shown that Tirzepatide can improve metabolism in patients with lipodystrophy. For example, in one case, a woman's triglycerides (a type of fat in the blood) dropped from 641 to 293 mg/dL after nine months of using Tirzepatide. This suggests that Tirzepatide may help lower high triglyceride levels in people with this condition. Researchers believe Tirzepatide might work by reducing appetite, which could improve diabetes control and lower triglycerides. While more research is needed, initial results are promising for those with partial lipodystrophy. Participants in this trial will either receive Tirzepatide first, followed by usual care, or start with usual care and then receive Tirzepatide, allowing researchers to compare the effects of these treatment sequences. ^{1 2 3 4 5}

Who Is on the Research Team?

Elif Oral, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals with partial lipodystrophy, a condition where there's abnormal loss of body fat. Participants should be experiencing issues like diabetes and high triglycerides due to their condition. The study will include those who are currently on usual care medications for these problems.

Inclusion Criteria

Hemoglobin A1c ≥ 7.0% at screening and after 12-week run-in period

Triglycerides ≥ 200 Milligrams Per Deciliter (mg/dL) at screening and after 12-week run-in period

Stable body weight during the 3 months prior to screening visit (no gain or loss of >5% current body weight)

Exclusion Criteria

Alcohol consumption >21 drinks per week for males or >14 drinks per week for females

Pregnant or breastfeeding persons

Known serious hypersensitivity to Tirzepatide or any of the excipients in Mounjaro

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

12 weeks

1 visit (in-person)

Run-in Period

Participants undergo a 12-week run-in period to stabilize on their regular diabetic and hypertriglyceridemia medications

12 weeks

Treatment Phase 1

Participants receive Tirzepatide with dose titration every 4 weeks for 24 weeks

24 weeks

Treatment Phase 2

Participants either discontinue Tirzepatide or begin commercial GLP-1 receptor agonist use while continuing regular medications

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tirzepatide

Trial Overview The trial is testing Tirzepatide, a medication that might help control diabetes and lower triglycerides in people with lipodystrophy by reducing caloric intake. It compares the effects of Tirzepatide against standard treatments already in use.

How Is the Trial Designed?

Group I: Usual care treatment then Tirzepatide (Group B) Experimental Treatment 2 Interventions

Participants will have a 12-week run-in period and then recheck of eligibility. Eligible participants randomized to this group will continue participant's regular diabetic and hypertriglyceridemia medications that were used during the run-in period for 24 weeks. During weeks 25-48 (phase 2) participants will receive Tirzepatide according to the dose titration plan described in the FDA-approved Prescribing Information (starting with 2.5 mg/week and increasing the dose every 4 weeks by increments of 2.5 milligrams (mg) for 24 weeks.

Group II: Tirzepatide then usual care (Group A) Experimental Treatment 2 Interventions

Participants will have a 12-week run-in period and then recheck of eligibility. Eligible participants randomized to this group will receive Tirzepatide according to the dose titration plan described in the FDA-approved Prescribing Information (starting with 2.5 mg/week and increasing the dose every 4 weeks by increments of 2.5 milligrams (mg) for 24 weeks (up to 15 mg over the course of 6 months). Phase 2 weeks 25-48: Discontinuation of Tirzepatide (patients may continue on protocol if commercial use of GLP-1 receptor agonist is begun during this phase). Participants will continue the regular diabetic and hypertriglyceridemia medications that were used during the run-in period for weeks 25-48.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Citations

1. diabetesjournals.org diabetesjournals.org/care/article/48/5/756/157974/Metabolic-Improvements-With-Tirzepatide-in

Metabolic Improvements With Tirzepatide in Lipodystrophy Here, we hypothesize that tirzepatide, a dual incretin, may also lead to metabolic improvement in patients with lipodystrophy.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07091734

NCT07091734 | Tirzepatide for Partial Lipodystrophy ... Study Hypothesis: - The clinical use of Tirzepatide in patients with lipodystrophy may lead to favorable outcomes through the reduction of caloric intake.

3. medrxiv.org medrxiv.org/content/10.1101/2024.09.25.24313345v1.full-text

Tirzepatide for Lipodystrophy At 9 months of follow-up, her triglycerides improved from 641 to 293 mg/dL (7.2 to 3.3 mmol/L). As a potential confounder, she was started on ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40063619/

Metabolic Improvements With Tirzepatide in Lipodystrophy Here, we hypothesize that tirzepatide, a dual incretin, may also lead to metabolic improvement in patients with lipodystrophy.

5. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.16175

Safety and effectiveness in an uncontrolled setting of ... Beneficial effects of SGLT2 inhibitors on metabolic complications has been reported in a series of 12 patients with partial lipodystrophy, which ...