A Phase 1/2 interventional study of AAV9-Follistatin gene therapy and VEGF Plasmid in Age-related Muscle Decline, sponsored by Unlimited Biotechnology LLC. Recruiting at 1 site in Honduras. Open to participants aged 35 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Unlimited Biotechnology LLC · Phase 1/2, Interventional, and Prevention
This Phase 1/2a, open-label, non-randomized study is designed to evaluate the safety and tolerability of intramuscular AAV9-Follistatin gene therapy administered either as monotherapy or in combination with a VEGF-encoding plasmid. Secondary objectives include the assessment of preliminary signals of biological and functional activity, including changes in skeletal muscle mass and performance.
Approximately 12 participants (with a potential expansion to 18-21) will be sequentially assigned to three cohorts: low-dose AAV-Follistatin monotherapy (n=3), high-dose AAV-Follistatin monotherapy (n=3), or combination therapy (AAV-Follistatin + VEGF plasmid, n=6). A cautious 3+3 dose-escalation design with sentinel dosing will be employed.
All investigational products are administered via intramuscular injection into large skeletal muscles. In Cohorts 1 and 2, AAV-Follistatin is administered once on Day 1. In Cohort 3, VEGF plasmid is administered on Day 1 and Day 12 (±2 days), followed by AAV-Follistatin on approximately Day 27 (±3 days), corresponding to 15 ± 1 days after the second VEGF plasmid dose.
Rapamycin will be administered for approximately two months to mitigate immune responses to the AAV vector. Participants will undergo regular safety monitoring, including clinical assessments, laboratory testing, and strength evaluations.
The study enrolls adults aged 35-75 years with evidence of age-related muscle decline, who are in generally stable health and able to provide informed consent and comply with study procedures. Eligible participants must demonstrate low or acceptable antibody titers to the AAV vector and hold Próspera ZEDE eResidency or Physical Residency.
Key exclusion criteria include: uncontrolled significant medical conditions; active or recent malignancy; clinically relevant immune disorders or current immunosuppressive therapy; pregnancy or breastfeeding; prior exposure to AAV-based gene therapy; or recent participation in other investigational studies.
Screening (up to 7 days) includes medical history, physical examination, laboratory tests, and baseline muscle assessments (e.g., DXA, strength, and functional testing). The core study period lasts approximately 90 days (for Group 3 = 120 days), with frequent safety assessments and functional evaluations. Participants may opt into extended safety follow-up at approximately 6 and 12 months.
Participation involves potential risks, including:
Direct clinical benefit cannot be guaranteed. Participants may experience improvements in muscle mass, strength, endurance, or functional performance; however, this is an early-phase trial primarily designed to assess safety and feasibility. The study may contribute to the development of future therapies for age-related muscle decline.
Participants should anticipate approximately three months of active participation, with optional follow-up extending to 12 months.
1,329 studies on the registry are indexed under Sarcopenia; 420 are open to participants now.
This study's planned enrollment of 12 is below the median of 60 across 855 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →This is the only study on the registry with Unlimited Biotechnology LLC as lead sponsor.
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.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a single intramuscular dose of AAV-Follistatin (5 × 10¹⁰ vg/kg) on Day 1. The total dose will be administered bilaterally across predefined injection sites in major limb muscles (quadriceps femoris, gluteus maximus, gastrocnemius, and biceps brachii) according to a standardized injection map. Rapamycin will be given per protocol for approximately two months to mitigate immune responses to the AAV vector. This sentinel cohort follows a sequential 3+3 dose-escalation design; dose-limiting toxicities will be assessed through Day 21 prior to escalation to Arm 2.
Genetic: AAV9-Follistatin gene therapy
After safety review of Arm 1, participants in Arm 2 will receive a single higher intramuscular dose of AAV-Follistatin (1 × 10¹¹ vg/kg) on Day 1, administered bilaterally across predefined injection sites in major limb muscles according to the same standardized injection map. Prophylactic immunomodulation with rapamycin will be provided per protocol for approximately two months, with identical safety monitoring procedures as in Arm 1. This cohort is intended to evaluate dose-dependent safety and tolerability of AAV-Follistatin monotherapy. Dose-limiting toxicities (DLTs) will be assessed through Day 21, and escalation to Arm 3 will proceed following review of safety data and confirmation of predefined criteria.
Genetic: AAV9-Follistatin gene therapy
Following safety review of Arm 2, participants in Arm 3 will receive VEGF plasmid (total dose 4.8 mg) administered intramuscularly on Day 1 and Day 12 (±2 days) across the same predefined bilateral muscle groups used for AAV-Follistatin (quadriceps femoris, gluteus maximus, gastrocnemius, and biceps brachii). AAV-Follistatin will then be administered 15 ± 1 days after the second VEGF dose (approximately Day 27-29) using the identical standardized injection map. The AAV dose for Arm 3 will be selected based on safety review of prior cohorts and will be either 5 × 10¹⁰ vg/kg or 1 × 10¹¹ vg/kg. Rapamycin will be provided per protocol for approximately two months beginning around the time of AAV administration to mitigate potential immune responses. This cohort evaluates the safety and feasibility of sequential VEGF-mediated vascular support combined with myoanabolic AAV-Follistatin gene therapy.
Genetic: AAV9-Follistatin gene therapy · Genetic: VEGF Plasmid
One-time intramuscular administration of an adeno-associated virus, serotype 9, (AAV9) vector encoding human follistatin.
Intramuscular supercoiled plasmid DNA gene therapy encoding vascular endothelial growth factor (VEGF).
Number of participants with treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs)
Incidence, severity, and relatedness of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), through Day 90, graded according to CTCAE
Time frame: Day 1 through Day 90 after AAV administration
Number of participants with dose-limiting toxicities (DLTs)
Incidence of protocol-defined dose-limiting toxicities (DLTs) within the 21-day DLT observation window following AAV administration
Time frame: Day 1 through Day 21 after AAV administration
Number of participants with predefined clinically significant laboratory abnormalities
Number of participants with any of the following laboratory abnormalities through Day 90 (Day 120 for Group 3): ALT or AST \>3× ULN; Total bilirubin \>2× ULN; Serum cystatin C ≥1.5× baseline; eGFR decline ≥25% from baseline; Hemoglobin \<120 g/L in men or \<110 g/L in women; Hemoglobin decrease ≥2 g/dL; Platelet count \<100 × 10⁹/L; Neutrophil count \<1.5 × 10⁹/L; Creatine kinase ≥5× ULN
Time frame: Day 1 through Day 90 after AAV administration
Number of participants with new-onset symptomatic heart failure or arrhythmias (CTCAE Grade ≥2)
Number of participants experiencing new-onset symptomatic heart failure or clinically significant arrhythmias graded ≥2 according to CTCAE v5.0 through Day 90 (Day 120 for Group 3)
Time frame: Day 1 through Day 90 after AAV administration
Number of participants with injection site reactions
Number of participants experiencing injection site reactions (pain, swelling, erythema, induration, or local inflammation), graded according to CTCAE v5.0, through Day 90 (Day 120 for Group 3)
Time frame: Day 1 through Day 90 after AAV administration
Number of participants who discontinue study treatment due to adverse events
Number of participants who discontinue study treatment due to adverse events through Day 90 (Day 120 for Group 3)
Time frame: Day 1 through Day 90 after AAV administration
Change from baseline in Appendicular Lean Mass Index (ALMI) measured by DXA
Change from baseline in Appendicular Lean Mass Index (ALMI) measured by dual-energy X-ray absorptiometry (DXA)
Time frame: Baseline through Month 12
Change from baseline in Bone Mineral Density (BMD) measured by DXA (g/cm²)
Change from baseline in bone mineral density (BMD) measured by dual-energy X-ray absorptiometry (DXA)
Time frame: Baseline through Month 12
Change from baseline in lower limb one-repetition maximum (1RM) strength (kg)
Change from baseline in maximal voluntary strength assessed by one-repetition maximum (1RM) testing, assessed using leg press 1RM testing
Time frame: Baseline through Month 12
Change from baseline in grip strength (kg)
Change from baseline in maximal grip strength (kg), assessed using standardized hand dynamometry
Time frame: Baseline through Month 12
Change from baseline in maximal oxygen uptake (VO₂max, mL/kg/min)
Change from baseline in maximal oxygen uptake (VO₂max, mL/kg/min), assessed by standardized cardiopulmonary exercise testing (CPET)
Time frame: Baseline through Month 12
Change from baseline in SF-36 Physical and Mental Component Summary scores
Change from baseline in health-related quality of life assessed by the Short Form-36 (SF-36) questionnaire (0-100 scale)
Time frame: Baseline through Month 12
Change from baseline in Clinical Frailty Scale (CFS) score
Change from baseline in frailty status assessed using the Clinical Frailty Scale (CFS) (1-9 scale)
Time frame: Baseline through Month 12
Change from baseline in serum follistatin concentration (ng/ml)
Change from baseline in serum follistatin levels, measured by enzyme-linked immunosorbent assay (ELISA), ng/ml
Time frame: Baseline through Month 12
Change from baseline in serum myostatin concentration (ng/mL)
Change from baseline in serum myostatin levels, measured by ELISA, ng/ml
Time frame: Baseline through Month 12
Change from baseline in serum IGF-1 concentration (ng/mL)
Change from baseline in serum IGF-1 concentration, measured using a validated assay, ng/ml
Time frame: Baseline through Month 12
Change in mid-arm circumference (cm)
Change from baseline in circumferential measurements (cm) of the mid-arm, assessed using standardized anthropometric techniques
Time frame: Baseline through Month 12
Change in mid-thigh circumference (cm)
Change from baseline in circumferential measurements (cm) of the mid-thigh, assessed using standardized anthropometric techniques
Time frame: Baseline through Month 12
Change in calf circumference (cm)
Change from baseline in circumferential measurements (cm) of the calf, assessed using standardized anthropometric techniques
Time frame: Baseline through Month 12
Change in hip circumference (cm)
Change from baseline in circumferential measurements (cm) of the gluteal (hip) regions, assessed using standardized anthropometric techniques
Time frame: Baseline through Month 12
Plan to share: Undecided
Started Jun 2026 (actual). Primary completion is estimated for Sep 2027, 15 months after the start.
How these figures are worked out, and which studies are left out of them.
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