Trial · NCT01488409

Effects of Acipimox on Mitochondrial Function in Obesity

NCT01488409, Phase 2, Completed, Massachusetts General Hospital; results first posted 2016-02-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effects of Acipimox on Mitochondrial Function in Obesity. Trials, record NCT01488409. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01488409

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effects of Acipimox on Mitochondrial Function in Obesity
NCT number: NCT01488409
Status: Completed
Phases: Phase 2
Enrollment: 39 participants, actual
Lead sponsor: Massachusetts General Hospital
Conditions: Abdominal Obesity, Insulin Resistance, Hypertriglyceridemia
Interventions: Acipimox, Placebo
First posted: 2011-12-08
Last updated: 2016-03-01
Results first posted: 2016-02-03

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Phosphocreatine Recovery (ViPCr) at 6-months	Change from Baseline to 6-months Visit	The rate of recovery of phosphocreatine concentration after depletion by exercise is considered a measurement of mitochondrial function. Change in phosphocreatine recovery from baseline to 6 months will therefore give a measurement of change in mitochondrial function. ViPCR is given -- a higher value indicates better mitochondrial function.
Secondary	Change From Baseline in Insulin Sensitivity at 6-months	Change from Baseline to 6-months visit	Change in insulin resistance assessed by hyperinsulinemic-euglycemic clamp study at Baseline and at 6-months. Change in insulin-stimulated glucose uptake (M) during 40 mU/m2/min insulin clamp is given.
Secondary	Change From Baseline in Mitochondrial Density at 6 Months	Change from Baseline to 6-months	Muscle tissue obtained from biopsy will be used to assess mitochondrial number and morphology by microscopes at Baseline and at 6-months. The change in mitochondrial density from 6 months to baseline is given.
Secondary	Change From Baseline in Intramyocellular Lipid Content at 6-months	Change from Baseline to 6-months	Change in tibialis intramyocellular lipid (IMCL) normalized to creatinine is given.
Secondary	Change From Baseline in Lipid Profile at 6-months	Change from Baseline to 6-months	Change in direct low density lipoprotein (LDL) cholesterol is given

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Phosphocreatine Recovery (ViPCr) at 6-months	Change from Baseline to 6-months Visit	all available data used	mM/s	MEAN
SECONDARY	Change From Baseline in Insulin Sensitivity at 6-months	Change from Baseline to 6-months visit	all available data used	mg/kg/min	MEAN
SECONDARY	Change From Baseline in Mitochondrial Density at 6 Months	Change from Baseline to 6-months	all available data used	percentage of total muscle fiber area	MEAN
SECONDARY	Change From Baseline in Intramyocellular Lipid Content at 6-months	Change from Baseline to 6-months	all available data used	ratio of IMCL peak to Creatinine peak	MEAN
SECONDARY	Change From Baseline in Lipid Profile at 6-months	Change from Baseline to 6-months	all available data used	mg/dL	MEAN

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Phosphocreatine Recovery (ViPCr) at 6-months	Acipimox	1.7	Standard Deviation 9.6	mM/s
Change From Baseline in Phosphocreatine Recovery (ViPCr) at 6-months	Placebo	1.6	Standard Deviation 10.8	mM/s
Change From Baseline in Insulin Sensitivity at 6-months	Acipimox	0.1	Standard Deviation 1.9	mg/kg/min
Change From Baseline in Insulin Sensitivity at 6-months	Placebo	0.2	Standard Deviation 1.4	mg/kg/min
Change From Baseline in Mitochondrial Density at 6 Months	Acipimox	0.4	Standard Deviation 1.3	percentage of total muscle fiber area
Change From Baseline in Mitochondrial Density at 6 Months	Placebo	0	Standard Deviation 1.6	percentage of total muscle fiber area
Change From Baseline in Intramyocellular Lipid Content at 6-months	Acipimox	-0.2	Standard Deviation 3.0	ratio of IMCL peak to Creatinine peak
Change From Baseline in Intramyocellular Lipid Content at 6-months	Placebo	0.0	Standard Deviation 2.3	ratio of IMCL peak to Creatinine peak
Change From Baseline in Lipid Profile at 6-months	Acipimox	-19	Standard Deviation 26	mg/dL
Change From Baseline in Lipid Profile at 6-months	Placebo	6	Standard Deviation 22	mg/dL

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Acipimox	20
Overall Study	STARTED	Placebo	19
Overall Study	COMPLETED	Acipimox	16
Overall Study	COMPLETED	Placebo	15
Overall Study	NOT COMPLETED	Acipimox	4
Overall Study	NOT COMPLETED	Placebo	4

Source ClinicalTrials.gov

Adverse events30

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Flushing	Skin and subcutaneous tissue disorders	Acipimox	8	20
other	Flushing	Skin and subcutaneous tissue disorders	Placebo	4	19
other	nausea	Gastrointestinal disorders	Acipimox	4	20
other	nausea	Gastrointestinal disorders	Placebo	3	19
other	Dizziness	General disorders	Acipimox	1	20
other	Dizziness	General disorders	Placebo	1	19
other	abdominal bloating	Gastrointestinal disorders	Acipimox	3	20
other	abdominal bloating	Gastrointestinal disorders	Placebo	2	19
other	dry mouth	General disorders	Acipimox	1	20
other	dry mouth	General disorders	Placebo	0	19

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Acipimox
Total, all-cause mortality	Placebo
Total, other adverse events	Acipimox	16	20
Total, other adverse events	Placebo	16	19
Total, serious adverse events	Acipimox	0	20
Total, serious adverse events	Placebo	0	19

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26691888	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Acipimox vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01488409

GET https://conductscience.org/api/trials/v1/NCT01488409/events?page=2

API reference For AI assistants