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Regional Lipolysis and Adipocyte Lipolysis Protein Stimulation

Plain-language guide to NCT06416969: early phase 1 non-randomized trial of Somatostatin, 24 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06416969
Phase
early phase 1
Status
recruiting participants
Start
2024-01-01
Completion (planned or actual)
2028-01-01
Participants
24 (estimated)
Design
non-randomized, open label (everyone knows who gets what), basic_science
Conditions studied
Obesity
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (early phase 1) is built around Somatostatin.

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.

It had two arms (groups): Obesity Group (experimental) and Lean Group (experimental).

Subjects that have upper body obesity will receive somatostatin plus epinephrine.

Subject wo are normal weight will receive somatostatin plus epinephrine.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 24 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Overweight/Obese volunteers will have a BMI 29.0 - 40.0 kg/m2. Female subjects 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. Current use of medications that alter fatty acid or adipose metabolism possibly given: if yes, exclude.

The full record lists 12 inclusion and 14 exclusion criteria; among the exclusions: individuals with a history of a disease process such as:; ischemic heart disease; atherosclerotic valvular disease.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Somatostatin study: the participants and staff both knew the treatment.

It started in 2024-01-01 with completion listed for 2028-01-01.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Free Fatty Acid (FFA) release from femoral, splanchnic and upper body subcutaneous adipose tissue (time frame: approximately 3.5 hours). stimulated FFA release in volunteers with and without obesity (time frame: approximately 3.5 hours).

It also tracked 1 secondary outcome, for example Role of reesterification in adipose tissue FFA release.

What This Means in Plain Language

Put simply, this is a early phase 1, non-randomized trial of Somatostatin in 24 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Somatostatin compound page, all human trials.

Our Notes on the Compound

Somatostatin: A 14-amino-acid hormone that switches off the release of several other hormones, including growth hormone and insulin.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.