Excessive Weight GainEarly Phase 1NCT06175403
A Study of Niacin Regulation
A Early Phase 1 study testing Niacin in people with Excessive Weight Gain, 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 things that "turn off" fat cells the same way as lean people. The 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
- Excessive Weight Gain
- What is being tested?
- Niacin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 31 May 2027
- 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 CRTU for at least 3 days prior to study.
- Overweight/Obese volunteers will have a BMI 29.0 - 40.0 kg/m2.
- 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 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 > 180 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; all women of childbearing potential will use an appropriate contraceptive method, including barrier method, oral contraceptive medication, contraceptive device or abstinence while participating in the study. They will confirm use of one of these methods.
- 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: HbA1C < 6.5% for non-diabetic UBO; 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.
- Smokers.
- Concomitant use of medications that can alter free fatty acid metabolism: high dose fish oil (>3g per day), (if yes, discontinue for 6 weeks); statins (if yes hold for 4 weeks and receive primary care provider's approval); Niacin; Fibrates; thiazolidinediones; Beta-blockers; Oral or injected corticosteroids or anabolic steroids; any history of use of pioglitazone; atypical antipsychotics.
- Allergy to lidocaine.
- Allergy to Niaspan documented by immunological testing.
- 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.
Kelli Lytle, PhD contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55904
Pamela A. Reich, 507-255-6062, reich.pamela@mayo.edu
Kelli A Lytle, PhD, lytle.kelli@mayo.edu
About this study
Official title: Niacin Regulation of Regional Adipose Tissue Lipolysis
Adults who gain most of their excess weight in the abdominal area typically do not respond to things that "turn off" fat cells the same way as lean people. The researchers are trying to understand why fat tissue responds differently in people with different body types.
- Conditions
- Excessive Weight Gain
- Being tested
- Niacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiacinDrug
Intravenous administration of dose titrated from 10 µg·kg FFM-1·min-1 to 30 µg·kg for approximately 4.5 hours on one occasion
| Study group | Role | What they receive |
|---|---|---|
| Upper body obesity | Experimental | Subjects identify with upper body obesity will receive Niacin to lean how fat cells in different regions of the body the response. Receives: Drug: Niacin |
| Normal weight | Experimental | Subjects identify with normal body weight will receive Niacin to lean how fat cells in different regions of the body the response. Receives: Drug: Niacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma free fatty acid (FFA) concentrations
Measurement of plasma free fatty acid (FFA) concentrations from femoral, upper body subcutaneous adipose tissue expressed as nmol•million adipocytes-1•min-1
Measured: Baseline, post treatment (approximately 4 hours)
Secondary outcomes (1)
pHSL/HSL response
Measure of pHSL/HSL level in subcutaneous biopsy samples
Measured: approx. 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start1 Jan 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive Weight GainStudies 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
- 32 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
- NCT06175403
- Sponsor's protocol ID
- 23-003673
- Other IDs
- 2R01DK040484-35A1
- Status last verified
- Apr 2026
- First submitted
- 7 Dec 2023
- Last updated
- 13 Apr 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Niacin Regulation of Regional Adipose Tissue Lipolysis
- ClinicalTrials.gov ID
- NCT06175403
- Acronym / sponsor ID
- 23-003673
- Conditions
- Excessive Weight Gain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 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
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 18 Dec 2023 (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 things that "turn off" fat cells the same way as lean people. The 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 |
|---|---|---|
| Upper body obesity | Experimental | Drug: NiacinSubjects identify with upper body obesity will receive Niacin to lean how fat cells in different regions of the body the response. |
| Normal weight | Experimental | Drug: NiacinSubjects identify with normal body weight will receive Niacin to lean how fat cells in different regions of the body the response. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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 CRTU for at least 3 days prior to study.
- Overweight/Obese volunteers will have a BMI 29.0 - 40.0 kg/m2.
- 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 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 > 180 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; all women of childbearing potential will use an appropriate contraceptive method, including barrier method, oral contraceptive medication, contraceptive device or abstinence while participating in the study. They will confirm use of one of these methods.
- 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;
Key exclusion criteria (6 listed)
- 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.
- Smokers.
- Concomitant use of medications that can alter free fatty acid metabolism: high dose fish oil (>3g per day), (if yes, discontinue for 6 weeks); statins (if yes hold for 4 weeks and receive primary care provider's approval); Niacin; Fibrates; thiazolidinediones; Beta-blockers; Oral or injected corticosteroids or anabolic steroids; any history of use of pioglitazone; atypical antipsychotics.
- Allergy to lidocaine.
- Allergy to Niaspan documented by immunological testing.
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 |
|---|---|---|
| NiacinIntravenous administration of dose titrated from 10 µg·kg FFM-1·min-1 to 30 µg·kg for approximately 4.5 hours on one occasion | Drug | Normal weight, Upper body obesity |
Primary outcome
Change in plasma free fatty acid (FFA) concentrations
Time frame: Baseline, post treatment (approximately 4 hours)
Measurement of plasma free fatty acid (FFA) concentrations from femoral, upper body subcutaneous adipose tissue expressed as nmol•million adipocytes-1•min-1
1 secondary outcome
pHSL/HSL response
Time frame: approx. 6 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 13 Apr 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Kelli Lytle, PhD contact
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 Niacin in people with Excessive Weight Gain, 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 7 inclusion and 6 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 13 Apr 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 Pamela Reich (507-255-6062, reich.pamela@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma free fatty acid (FFA) concentrations (time frame: Baseline, post treatment (approximately 4 hours)). 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 13 Apr 2026.