Tirzepatide for Partial Lipodystrophy Treatment: A New Horizon in 2024

Conditions

• Lipodystrophy, Partial

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tirzepatide — DRUG
  Participants will receive study drug (Tirzepatide) according to the dose titration plan described in the FDA-approved Prescribing Information (starting with 2.5 mg/wk and increasing the dose every 4 weeks by increments of 2.5 mg. Additionally, participants will have visits (virtual or remote visits every four weeks) as well as various tests and evaluations during the trial.
• Usual care medications — DRUG
  Participant's will continue on participant's regular diabetic and hypertriglyceridemia medications that were used during the run-in period for 24 weeks. This will be either Phase 1 or Phase 2 based on randomization. Additionally, participants will have visits (virtual or remote visits every four weeks) as well as various tests and evaluations during the trial.

Study Details

This study aims to see if the clinical use of Tirzepatide in patients with lipodystrophy (a rare disorder associated with abnormal loss of the body's fat tissue) may lead to improved diabetes mellitus control and lowering of participant's triglycerides through the reduction of caloric intake. Study Hypothesis: \- The clinical use of Tirzepatide in patients with lipodystrophy may lead to favorable outcomes through the reduction of caloric intake.

Key Dates

Start date

Sep 8, 2025

Status verified

Sep 2025

Primary completion

Sep 30, 2029

Completion

Sep 30, 2029

Study Design

Enrollment

32 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Tirzepatide then usual care (Group A)
  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.
• Experimental: Usual care treatment then Tirzepatide (Group B)
  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.

Primary Outcome Measure

Change in Body Mass Index (BMI) from baseline in Group A (Tirzepatide-treated) versus Group B (control) at 24 weeks [ Time Frame: Baseline, 24 weeks ]

Central Contacts

• Adam Neidert, MS
  734-615-0539
  [email protected]

Locations (1)

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