A Phase 2/3 interventional study of Leptin and Placebo in Hypoleptinemia, Generalized Lipodystrophy and Partial Lipodystrophy, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 6 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-03-27.
Sponsored by University of Texas Southwestern Medical Center · Phase 2/3, Interventional, and Treatment
Lipodystrophies represent a therapeutic challenge with regards to insulin resistance, hypertriglyceridemia and fatty liver which often is coupled with significant adipose tissue loss. The purpose of the study is to examine the safety and efficacy of Leptin on subjects with lipodystrophy.
The mechanism by which leptin improves glucose and lipid control is not clear. We will examine the possible mechanisms of leptin action by studying the effects of leptin administration on food intake, insulin resistance, insulin secretory response, hepatic and intramuscular triglyceride stores in a large sample of patients with lipodystrophy.
Hypothesis: Leptin replacement in patients with generalized and partial lipodystrophy and hypoleptinemia will be safe and efficacious in improving the metabolic abnormalities associated with insulin resistance.
2,969 studies on the registry are indexed under Insulin Resistance; 338 are open to participants now.
This study's enrollment of 25 is below the median of 40 across 2,369 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Presence of at least one of the following metabolic abnormalities:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active Comparator for 4 months, then for 8 months.
Drug: Leptin
Placebo for 4 months, then active comparator for 8 months.
Drug: Placebo
Leptin injected subcutaneously twice a day, to be administered at 100% of the estimated replacement dose during the first month, which is a dosage of 0.03mg/kg for female children, 0.04mg/kg for adult females, and0.02 mg/kg for all males, and then at 200% subsequently, or placebo.
Also known as: Recombinant-methionyl Human Leptin., r-metHuLeptin
Sugar pill
Fasting Serum Triglycerides
Time frame: 4 months
HbA1c
Time frame: 4 months
Fasting Serum Glucose
Time frame: 4 months
Body Weight
Time frame: 4 months
| Milestone | Leptin Therapy | Placebo |
|---|---|---|
| Started | 13 | 12 |
| Completed | 10 | 9 |
| Not completed | 3 | 3 |
| mg/dL | Leptin Therapy | Placebo |
|---|---|---|
| Fasting Serum Triglycerides | 203 (100 to 457) | 304 (129 to 3875) |
| % of haemoglobin | Leptin Therapy | Placebo |
|---|---|---|
| HbA1c | 8.1 (5 to 12) | 7.6 (5.1 to 11.5) |
| mg/dL | Leptin Therapy | Placebo |
|---|---|---|
| Fasting Serum Glucose | 162 (77 to 310) | 165 (77 to 327) |
| kg | Leptin Therapy | Placebo |
|---|---|---|
| Body Weight | 62.5 ± 17.5 | 56.3 ± 17.6 |
Collected over 4 month. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Leptin Therapy | 0/13 (0%) | 0/13 (0%) | 2/13 (15.4%) |
| Placebo | 0/12 (0%) | 0/12 (0%) | 4/12 (33.3%) |
| Event | Leptin Therapy | Placebo |
|---|---|---|
| PneumoniaBlood and lymphatic system disorders | 0/13 | 1/12 |
| TonsillectomySurgical and medical procedures | 0/13 | 1/12 |
| Right Ankle PainSurgical and medical procedures | 0/13 | 1/12 |
| Blurry Vision and Epigastric painEye disorders | 0/13 | 1/12 |
| viral illness, sinusitis, backacheInfections and infestations | 1/13 | 0/12 |
| HeadachesGeneral disorders | 1/13 | 0/12 |
| Age, Continuous(years) | Leptin Therapy | Placebo | Total |
|---|---|---|---|
| Mean | 27.2 ± 11.9 | 24.9 ± 13 | 26.1 ± 12.2 |
| Sex: Female, Male(Participants) | Leptin Therapy | Placebo | Total |
|---|---|---|---|
| Female | 10 | 9 | 19 |
| Male | 3 | 3 | 6 |
| Body weight(kg) | Leptin Therapy | Placebo | Total |
|---|---|---|---|
| Mean | 65.5 ± 17.5 | 57.7 ± 16.0 | 61.8 ± 16.9 |
| Fasting serum Triglycerides(mg/dL) | Leptin Therapy | Placebo | Total |
|---|---|---|---|
| Median | 309.3 (69.3 to 1096.7) | 443.8 (104.7 to 3556.3) | 309.3 (69.3 to 3556.3) |
| Fasting serum Glucose(mg/dL) | Leptin Therapy | Placebo | Total |
|---|---|---|---|
| Mean | 157.0 ± 74.2 | 184.0 ± 87.2 | 170.0 ± 80.2 |
| HbA1c(% of haemoglobin) | Leptin Therapy | Placebo | Total |
|---|---|---|---|
| Mean | 8.1 ± 2.5 | 8.0 ± 2.5 | 8.0 ± 2.5 |
The record gives a start of Apr 2006, a primary completion of Nov 2014 and a completion of Nov 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2019, 4 years 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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