ObesityEarly Phase 1NCT06416969
Regional Lipolysis and Adipocyte Lipolysis Protein Stimulation
A Early Phase 1 study testing Somatostatin and Epinephrine in people with Obesity, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Somatostatin and Epinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 1 Jan 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 Clinical Research and Trials Unit for at least 3 days prior to study.
- 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 scan, usually with > 120 cm2 of visceral fat by CT scanning or a visceral fat/total fat ratio of > 0.30, and/or biochemical evidence of metabolic syndrome as defined by adenosine triphosphate (ATP) III criteria (fasting plasma triglycerides ≥ 150 mg/dL, HDL-cholesterol < 50 mg/dL for women and < 40 mg/dL for men, fasting plasma glucose ≥ 100 mg/dL). Upper body obesity in men will be defined as a waist-hip ratio of >0.95 and/or increased visceral fat (visceral fat area > 120 cm2 or a visceral/total fat abdominal ratio by CT of > 0.40) by single slice CT scan and/or biochemical evidence of metabolic syndrome as defined by ATP III criterial. These visceral fat values are based upon the data collected at Mayo Clinic using our methods, and are correlated with dyslipidemia and hyperinsulinemia.
- 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.
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- 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 12 weeks after their participation in the other study is complete or > than five half-lives of the compound, whichever is longer. If Yes look at consent form and f/u visits:
- 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
Who cannot join
- 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.
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- 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; thiazolidinedione; Beta-blockers; Oral or injected corticosteroids or anabolic steroids; Linezolid; Dihydroergotamine; Phenelzine; daily phosphodiesterase inhibitors
- Allergy to lidocaine
- Allergy to indocyanine green.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Madeline Reid, 507-255-6062, reid.madeline@mayo.edu
Kelli A Lytle, PhD, (507) 255-1488, lytle.kelli@mayo.edu
About this study
Official title: Stimulation of Regional Lipolysis and Adipocyte Lipolysis Proteins
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.
- Conditions
- Obesity
- Being tested
- Somatostatin, Epinephrine
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatostatinDrug
Intravenous infusion 200 ug/hr for 2 hours, 100 ug/hr for 30 minutes
EpinephrineDrug
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Obesity Group | Experimental | Subjects that have upper body obesity will receive somatostatin plus epinephrine Receives: Drug: Somatostatin; Drug: Epinephrine |
| Lean Group | Experimental | Subject wo are normal weight will receive somatostatin plus epinephrine Receives: Drug: Somatostatin; Drug: Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free Fatty Acid (FFA) release from femoral, splanchnic and upper body subcutaneous adipose tissue
regional palmitate release rates (micromol/min) will be measured using a combination of leg and splanchnic blood flow combined with stable isotope tracer measurements of palmitate uptake and release across the leg and splanchnic bed. Upper body, non-splanchnic palmitate release will be calculated as: total palmitate release - (splanchnic palmitate release + (leg palmitate release x 2)). Release rates will be measured at baseline (overnight fasting) and in response to the infusion of somatostatin plus epinephrine. This will allow us to understand the factors that may limit maximum lipolysis stimulation in upper body obesity for leg, splanchnic and upper body non-splanchnic adipose tissue palmitate release.
Measured: approximately 3.5 hours
stimulated FFA release in volunteers with and without obesity.
we will measure whether stimulated adipose tissue lipolysis from infusions of somatostatin and epinephrine is impaired in UBO and, if so, if this is related to regional differences in lipolysis and lipolysis-regulating proteins;
Measured: approximately 3.5 hours
Secondary outcomes (1)
Role of reesterification in adipose tissue FFA release
We will measure the regional FFA:glycerol release ratio, a measure of intracellular reesterification, differs between UBO and non-UBO adults in a way that accounts for the differences in systemic FFA delivery. This will require the use of both FFA and glycerol tracers.
Measured: approximately 3.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael D. Jensen, Mayo Clinic
- Investigators
- Michael Jensen, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416969
- Sponsor's protocol ID
- 23-004069
- Other IDs
- R01DK040484
- Status last verified
- May 2026
- First submitted
- 1 May 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulation of Regional Lipolysis and Adipocyte Lipolysis Proteins
- ClinicalTrials.gov ID
- NCT06416969
- Acronym / sponsor ID
- 23-004069
- Conditions
- Obesity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obesity Group | Experimental | Drug: Somatostatin, Drug: EpinephrineSubjects that have upper body obesity will receive somatostatin plus epinephrine |
| Lean Group | Experimental | Drug: Somatostatin, Drug: EpinephrineSubject wo are normal weight will receive somatostatin plus epinephrine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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 Clinical Research and Trials Unit for at least 3 days prior to study.
- 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 scan, usually with > 120 cm2 of visceral fat by CT scanning or a visceral fat/total fat ratio of > 0.30, and/or biochemical evidence of metabolic syndrome as defined by adenosine triphosphate (ATP) III criteria (fasting plasma triglycerides ≥ 150 mg/dL, HDL-cholesterol < 50 mg/dL for women and < 40 mg/dL for men, fasting plasma glucose ≥ 100 mg/dL). Upper body obesity in men will be defined as a waist-hip ratio of >0.95 and/or increased visceral fat (visceral fat area > 120 cm2 or a visceral/total fat abdominal ratio by CT of > 0.40) by single slice CT scan and/or biochemical evidence of metabolic syndrome as defined by ATP III criterial. These visceral fat values are based upon the data collected at Mayo Clinic using our methods, and are correlated with dyslipidemia and hyperinsulinemia.
- Female subjects are eligible if they meet the following criteria:
- 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 12 weeks after their participation in the other study is complete or > than five half-lives of the compound, whichever is longer. If Yes look at consent form and f/u visits:
Key exclusion criteria (14 listed)
- Individuals with a history of a disease process such as:
- 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; thiazolidinedione; Beta-blockers; Oral or injected corticosteroids or anabolic steroids; Linezolid; Dihydroergotamine; Phenelzine; daily phosphodiesterase inhibitors
- Allergy to lidocaine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SomatostatinIntravenous infusion 200 ug/hr for 2 hours, 100 ug/hr for 30 minutes | Drug | Lean Group, Obesity Group |
| EpinephrineIntravenous infusion | Drug | Lean Group, Obesity Group |
Primary outcome
Free Fatty Acid (FFA) release from femoral, splanchnic and upper body subcutaneous adipose tissue
Time frame: approximately 3.5 hours
regional palmitate release rates (micromol/min) will be measured using a combination of leg and splanchnic blood flow combined with stable isotope tracer measurements of palmitate uptake and release across the leg and splanchnic bed. Upper body, non-splanchnic palmitate release will be calculated as: total palmitate release - (splanchnic palmitate release + (leg palmitate release x 2)). Release rates will be measured at baseline (overnight fasting) and in response to the infusion of somatostatin plus epinephrine. This will allow us to understand the factors that may limit maximum lipolysis stimulation in upper body obesity for leg, splanchnic and upper body non-splanchnic adipose tissue palmitate release.
stimulated FFA release in volunteers with and without obesity.
Time frame: approximately 3.5 hours
we will measure whether stimulated adipose tissue lipolysis from infusions of somatostatin and epinephrine is impaired in UBO and, if so, if this is related to regional differences in lipolysis and lipolysis-regulating proteins;
1 secondary outcome
Role of reesterification in adipose tissue FFA release
Time frame: approximately 3.5 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Jensen, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Somatostatin and Epinephrine in people with Obesity, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madeline Reid ((507) 255-6062, reid.madeline@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Free Fatty Acid (FFA) release from femoral, splanchnic and upper body subcutaneous adipose tissue (time frame: approximately 3.5 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.