Partial LipodystrophyPhase 3METRE-PLNCT05164341
Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With PL
A Phase 3 study testing metreleptin in people with Partial Lipodystrophy, run by Chiesi Farmaceutici S.p.A. at 31 sites in 9 countries.
Trial summary
This is a Phase III, double-blind, placebo-controlled, safety and efficacy study of daily SC metreleptin in subjects with Partial Lipodystrophy. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Partial Lipodystrophy
- What is being tested?
- metreleptin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 31 sitesin 9 countries
- Study dates
- 17 Dec 2021to 31 Oct 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of Familial Partial Lipodystrophy (FPLD)
- Subjects with poor metabolic control defined as:
- HbA1c ≥7% (at Visit 1 and Visit 3) and/or Fasting TGs ≥500 mg/dL (5.65 mmol/L, at Visit 1 and Visit 3)
- Patients should be receiving optimized stable therapy
Who cannot join
- Previous treatment with metreleptin
- Leptin levels >20.0 ng/mL
- Acquired or radiation induced partial lipodystrophy (APL)
- Other protocol defined inclusion/exclusion criteria apply
Trial locations and contacts
31 sites in 9 countries.
31 sites in 9 countries
United States13 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30329
University of Alabama
Birmingham, Alabama, 35233
Flourish Boca Raton
Boca Raton, Florida, 33431
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Missouri
Columbia, Missouri, 65212
Amryt Research Site, Endocrinology Research Associates Inc
Columbus, Ohio, 43201
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
UT Southwestern Medical Center
Dallas, Texas, 75390
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55902
UC Davis
Sacramento, California, 95817
Canada6 sites
Ecogene-21
Chicoutimi, Quebec, G7H 7K9
Nova Scotia Health
Halifax, Nova Scotia, B3H 2Y9
Hamilton General Hospital- McMaster University
Hamilton, Ontario, L8N 3Z5
London Health Science Centre
London, Ontario, N6A 5B7
Faculty of Medicine, Universite Laval
Québec, Quebec, G1V4W2
Care Access Clinic
Sydney, Nova Scotia, B1M 0A1
Brazil4 sites
Universitário Walter Cantídio
Fortaleza
Insight Centro de Pesquisas
Porto Alegre
Hospital das Clinicas FMRP-USP
Ribeirão Preto
Instituto Estadual de Diabetes e Endocrinologia (IEDE-RJ)
Rio de Janeiro
Netherlands2 sites
Leids Universitair Medisch Centrum
Leiden
Radboud University Medical Centre Interne Geneeskund
Nijmegen
Poland2 sites
Uniwersyteckie Centrum Kliniczne
Katowice
SPZOZ Szpital Uniwersytecki w Krakowie
Krakow
Spain1 site
University Clinical Hospital of Santiago de Compostela/Hospital Universitario
Santiago de Compostela
About this study
Official title: A 12-Month Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With Partial Lipodystrophy
This is a Phase III, double-blind, placebo-controlled, safety and efficacy study of daily SC metreleptin in subjects with Partial Lipodystrophy.
- Conditions
- Partial Lipodystrophy
- Being tested
- metreleptin, Placebo
- Keywords
- metreleptin
- Medical subject headings
- Lipodystrophy, Partial, Acquired
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metreleptinDrug
Metreleptin is a recombinant human leptin analog that is indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| metreleptin | Active comparator | Metreleptin [Recombinant-methionyl human Leptin; r-metHuLeptin] for daily injection is a sterile, white, solid lyophilised cake Receives: Drug: metreleptin |
| placebo | Placebo comparator | Placebo for daily injection is a sterile, white, solid lyophilised cake Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to month 6 in HbA1c in subjects with partial lipodystrophy (PL)
To evaluate the efficacy (HbAa1c) of daily SC metreleptin treatment
Measured: 6 months
Percent change from Baseline to month 6 in fasting TGs in subjects with partial lipodystrophy (PL)
To evaluate the efficacy (TGs) of daily SC metreleptin treatment
Measured: 6 months
Secondary outcomes (4)
Safety analysis of AEs, AESIs, SAEs by treatment arm
To evaluate the safety of daily SC metreleptin treatment in subjects with PL
Measured: 12 months
Change from baseline to months 9 and 12 in HbA1c in subjects with partial lipodystrophy (PL)
To assess the effect of metreleptin on HbA1c
Measured: 12 months
Percent change from baseline to months 9 and 12 in fasting TGs in subjects with partial lipodystrophy (PL)
To assess the effect of metreleptin on TGs
Measured: 12 months
Change from Baseline to each assessment time point in quality of life (QoL) in all subjects
To assess the effect of metreleptin on quality of life (QoL) in all subjects
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start17 Dec 2021
- Primary completion21 Jul 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial LipodystrophyStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164341
- Sponsor's protocol ID
- APG-20
- Acronym
- METRE-PL
- Status last verified
- Jun 2026
- First submitted
- 11 Nov 2021
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Month Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With Partial Lipodystrophy
- ClinicalTrials.gov ID
- NCT05164341
- Acronym / sponsor ID
- METRE-PL / APG-20
- Conditions
- Partial Lipodystrophy
- Keywords
- metreleptin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 21 Jul 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 20 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase III, double-blind, placebo-controlled, safety and efficacy study of daily SC metreleptin in subjects with Partial Lipodystrophy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metreleptin | Active comparator | Drug: metreleptinMetreleptin [Recombinant-methionyl human Leptin; r-metHuLeptin] for daily injection is a sterile, white, solid lyophilised cake |
| placebo | Placebo comparator | Drug: PlaceboPlacebo for daily injection is a sterile, white, solid lyophilised cake |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Familial Partial Lipodystrophy (FPLD)
- Subjects with poor metabolic control defined as:
- HbA1c ≥7% (at Visit 1 and Visit 3) and/or Fasting TGs ≥500 mg/dL (5.65 mmol/L, at Visit 1 and Visit 3)
- Patients should be receiving optimized stable therapy
Key exclusion criteria (4 listed)
- Previous treatment with metreleptin
- Leptin levels >20.0 ng/mL
- Acquired or radiation induced partial lipodystrophy (APL)
- Other protocol defined inclusion/exclusion criteria apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metreleptinMetreleptin is a recombinant human leptin analog that is indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency | Drug | metreleptin |
| PlaceboPlacebo | Drug | placebo |
Primary outcome
Change from baseline to month 6 in HbA1c in subjects with partial lipodystrophy (PL)
Time frame: 6 months
To evaluate the efficacy (HbAa1c) of daily SC metreleptin treatment
Percent change from Baseline to month 6 in fasting TGs in subjects with partial lipodystrophy (PL)
Time frame: 6 months
To evaluate the efficacy (TGs) of daily SC metreleptin treatment
4 secondary outcomes
Safety analysis of AEs, AESIs, SAEs by treatment arm
Time frame: 12 months
Change from baseline to months 9 and 12 in HbA1c in subjects with partial lipodystrophy (PL)
Time frame: 12 months
Percent change from baseline to months 9 and 12 in fasting TGs in subjects with partial lipodystrophy (PL)
Time frame: 12 months
Change from Baseline to each assessment time point in quality of life (QoL) in all subjects
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing metreleptin in people with Partial Lipodystrophy, run by Chiesi Farmaceutici S.p.A. at 31 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Canada, Brazil, Netherlands, Poland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to month 6 in HbA1c in subjects with partial lipodystrophy (PL) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.