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New treatment option for Obesity
Official title Regional Lipolysis and Adipocyte Lipolysis Protein Stimulation
ClinicalTrials.gov ID: NCT06416969
What this study is testing
What is Somatostatin?
Somatostatin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for obesity.
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
- Adults who gain most of their excess weight in the abdominal area typically do not respond to factors that "turn on" fat cells the same way as people who don't have excessive weight. Researchers are trying to understand why fat tissue responds differently in people with different body types.
- Phase 1: an early, usually small safety study
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 65. Healthy volunteers may be eligible.
You may be able to join if
- Males and females between 18 and 65 years of age who are able to comprehend instructions, follow study procedures, willing to sign an informed...
- Overweight/Obese volunteers will have a BMI 29.0 - 40.0 kg/m2 o Upper body/visceral obesity (UBO) in women will be defined as those with a waist-hip...
- Female people are eligible if they meet the following criteria:
- Are not pregnant or nursing
- All women of childbearing potential will have a negative urine pregnancy test at screening and a negative urine pregnancy test within 48 hours before...
You likely can't join if
- Individuals with a history of a disease process such as:
- Ischemic heart disease
- Atherosclerotic valvular disease
- Persistent blood pressure greater than 160/95 despite antihypertensive medication
- Peripheral artery disease
- Any history of trans-ischemic attacks.
See the full eligibility criteria
- Males and females between 18 and 65 years of age who are able to comprehend instructions, follow study procedures, willing to sign an informed consent form, and consume an isoenergetic diet eating all meals from Mayo...
- Overweight/Obese volunteers will have a BMI 29.0 - 40.0 kg/m2 o Upper body/visceral obesity (UBO) in women will be defined as those with a waist-hip ratio (WHR) \> 0.85 and/or increased visceral fat by single slice CT...
- Female people are eligible if they meet the following criteria:
- Are not pregnant or nursing
- All women of childbearing potential will have a negative urine pregnancy test at screening and a negative urine pregnancy test within 48 hours before administering study drug.
- Recent or current research participation in a study that involves an investigational drug. Participants in other clinical trials that involve an investigational drug will not be able to participate in this study until...
- Current use of medications that alter fatty acid or adipose metabolism possibly given: if yes, exclude
- Amount of blood drawn during the study (if our study plus this one draw ≥ 450 ml these should be separated by 8 weeks
- Previous labs:
- Fasting glucose \< 126 mg/dl for non-diabetic UBO
- Hb ≥ 11.0 for women and ≥ 12 for men
- platelets \> 100 000
- Individuals with a history of a disease process such as:
- Ischemic heart disease
- Atherosclerotic valvular disease
- Persistent blood pressure greater than 160/95 despite antihypertensive medication
- Peripheral artery disease
- Any history of trans-ischemic attacks.
- Coronary artery disease.
- Liver cirrhosis
- Significant renal impairment as documented in medical chart.
- Smokers
- Diagnosis of Diabetes Mellitus.
- Concomitant use of medications that can alter free fatty acid metabolism or pose a drug-drug interaction: statins (if yes hold for 4 weeks and receive primary care provider's approval); Niacin; Fibrates...
- Allergy to lidocaine
- Allergy to indocyanine green.
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, 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 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, 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.