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New treatment option for Healthy
Official title Effects of GH and Lirglutide on AgRP
ClinicalTrials.gov ID: NCT05681299
What this study is testing
What is growth hormone and lirglutide?
growth hormone and lirglutide is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for healthy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a randomized, placebo-controlled, cross-over study with 4 arms. Healthy and GH deficient adults ages 18-45 years will be studied.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join if
- HEALTHY people
- 40 healthy people, 20 male, 20 female, ages 18-45 yr.: (i) 20 (10 male, 10 female) who are overweight/Class 1 Obese (BMI 25-34.9) with abdominal fat...
- No medical conditions except being overweight/obese in half of people
- No prescription medication or other drug use
- On screening testing: BP\<140/\<90 mmHg, HbA1c\<5.7%, FPG\<100 mg/dL, normal IGF-1 and TSH levels.
You likely can't join if
- HEALTHY people
- History of malignancy, diabetes, thyroid cancer or pancreatitis
- Recent dieting, weight change \>5%, pregnancy or lactation or heavy exercise
- Use of glucocorticoids, hormonal supplements or medications that could affect GH or IGF-1 or for weight loss within 6 months of enrollment GH...
- DM requiring medication
- HbA1C \> 7.5
See the full eligibility criteria
- HEALTHY people
- 40 healthy people, 20 male, 20 female, ages 18-45 yr.: (i) 20 (10 male, 10 female) who are overweight/Class 1 Obese (BMI 25-34.9) with abdominal fat accumulation (central adiposity) defined by waist circumference (WC) ≥...
- No medical conditions except being overweight/obese in half of people
- No prescription medication or other drug use
- On screening testing: BP\<140/\<90 mmHg, HbA1c\<5.7%, FPG\<100 mg/dL, normal IGF-1 and TSH levels.
- Premenopausal women: use of nonhormonal method of contraception
- Current non-smoker GH DEFICIENT people
- 24 patients with isolated GH deficiency:12 males, 12 females.
- Ages 18-45 years
- Diagnosis of isolated GH deficiency based on accepted, BMI-appropriate GH stimulation test cut offs within 12 months of enrollment
- No prior GH therapy within 12 months of study enrollment
- Normal thyroid, adrenal and gonadal function documented by accepted stimulation test and clinical criteria
- Premenopausal women: use of nonhormonal method of contraception
- HEALTHY people
- History of malignancy, diabetes, thyroid cancer or pancreatitis
- Recent dieting, weight change \>5%, pregnancy or lactation or heavy exercise
- Use of glucocorticoids, hormonal supplements or medications that could affect GH or IGF-1 or for weight loss within 6 months of enrollment GH DEFICIENT people
- DM requiring medication
- HbA1C \> 7.5
- Malignancy, pancreatitis or thyroid cancer history.
- Deficiency of other pituitary hormones, liver or renal disease
- Use of glucocorticoids, hormonal supplements or medications that could affect GH or IGF-1 or for weight loss within 6 months of enrollment 5\. Recent dieting, weight change \> 5%, pregnancy, lactation or heavy exercise...
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.