ObesityNCT04687540
Meal-regulated Substrate Metabolism, Influence of Obesity and IL-6
A study testing Tocilizumab and Saline 0.9% in people with Obesity and Healthy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The overall purpose of this explorative yet quantitative study project is to understand how blocking IL-6 signaling leads to the expansion of adipose tissue mass in humans in vivo. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- What is being tested?
- Tocilizumab and Saline 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Apr 2021to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males:
- Age ≥ 18 years and ≤ 40 years
- BMI < 18 and > 25 kg/m2
- Healthy (based on screening)
- Stable body weight for 6 months
- Obese males:
Show all 10Show fewer
- Age ≥ 18 years and ≤ 40 years
- BMI ≥ 30 and ≤ 40 kg/m2
- Healthy (based on screening)
- Stable body weight for 6 months
Who cannot join
- Smoking
- Evidence of severe thyroid or heart disease, inflammatory diseases, current infection, liver disease (transaminases >2x upper normal range), kidney disease (creatinine >1.5 mg/dl), known immunosuppressive disease, corticosteroid use, regular NSAID or paracetamol usage, aspirin use >100 mg/d, history of carcinoma, history of tuberculosis, anemia (hematocrit <33%), WBC <2 x 10^3/ul, platelets <100 x 10^3/ul, bleeding disorders, obstructive pulmonary disease
- Femoral hernia, vascular prosthesis, vascular thrombosis
- Previous nerve damage, many previous femoral catheter installations
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Rigshospitalet, Centre of Inflammation and Metabolism (CIM) Centre for Physical Activity Research (CFAS)
Copenhagen, 2100
About this study
The overall purpose of this explorative yet quantitative study project is to understand how blocking IL-6 signaling leads to the expansion of adipose tissue mass in humans in vivo. The aim is to gain in depth knowledge about how IL-6 receptor blockade affects human lipid, glucose and protein metabolism, specifically the uptake and storage of substrates from a meal vs. their utilization, hence the balance determining whether one gains or loses fat mass.
Read the detailed description
Lacking IL-6 signaling leads to an expansion of adipose tissue mass in rodents and humans. However, the underlying mechanisms have not been identified.This project aims to investigate the overall hypothesis that IL-6 receptor blockade changes substrate metabolism during postabsorptive and postprandial states to favor storage over mobilization of fat and to favor glucose over fat as a source for energy production. This hypothesis finds some support in the literature: Infusion of recombinant IL-6 into humans, leading to high concentrations of IL-6 in the circulation, stimulates lipolysis and free fatty acid oxidation.
Therefore, the investigators hypothesize that IL-6 receptor blockade impairs the mobilization of FFA from adipose tissue and impairs fat oxidation in skeletal muscle in the postabsorptive state. In the postprandial, state the investigators hypothesize that IL-6 receptor blockade reduces the insulin-induced uptake and deposition of fat by adipose tissue and skeletal muscle, therefore contributing to ectopic fat deposition in the liver.
In this study 12 lean and 12 obese male participants will be included. The participants will attend one screening visit and two study visits. The IL-6 receptor antibody tocilizumab will be infused on study visit 1.
Isotope dilution techniques, blood flow measurements, arterio-venous differences across adipose tissue and skeletal muscle, fat and skeletal muscle biopsies will be used to assess lipid, glucose and protein kinetics on a whole-body as well as fat and skeletal muscle level in the fasting state and after the ingestion of a liquid mixed-meal. Respiratory exchange ratio will be measured by indirect calorimetry.
- Being tested
- Tocilizumab, Saline 0.9%
- Keywords
- Interleukin-6, Tocilizumab, Postprandial, Postabsorptive, Substrate metabolism, Fat metabolism, Glucose metabolism, Protein metabolism, Isotope dilution technique
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
Also called RoActemra
Baseline: Tocilizumab (infusion of 8 mg/kg bodyweight or a maximum of 800 mg) will be infused over 60 minutes at the end for the study day, therefore study visit 1 (study day 1) measurements are baseline.
Saline 0.9%Drug
Participants are under influence of tocilizumab since the effect of the drug will last for 4 weeks. Participants will be infused with saline at study visit 2 (study day 21). Placebo to tocilizumab will be saline (NaCl 0.9%) as tocilizumab is a colorless solution and has to be diluted with NaCl 0.9% prior to administration
| Study group | Role | What they receive |
|---|---|---|
| Study day 1 (study visit 1) | Placebo comparator | Baseline measurements (pre-intervention) are obtained on study visit 1. Receives: Drug: Tocilizumab |
| Study day 21 (study visit 2) | Active comparator | Post-intervention measurements: Participants will be under the influence of tocilizumab, which was injected at the end of study visit 1. Receives: Drug: Saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-body, fat and skeletal muscle fat turnover
Rate of appearance and disappearance of glycerol and palmitate, fatty acid oxidation and re-esterification, arterio-venous differences of glycerol, palmitate, triglycerides across adipose tissue and skeletal muscle, triglycerides fractional synthesis rate in the postabsorptive and postprandial state in the presence of tocilizumab as compared to placebo
Measured: 0-21 days
Whole-body, fat and skeletal muscle glucose turnover
Rate of appearance and disappearance of glucose, arterio-venous differences of glucose across adipose tissue and skeletal muscle, glycogen fractional synthesis rate in the postabsorptive and postprandial state in the presence of tocilizumab as compared to placebo
Measured: 0-21 days
Whole-body, fat and skeletal muscle amino acid and protein turnover
Rate of appearance and disappearance of amino acids, arterio-venous differences of amino acids across adipose tissue and skeletal muscle, protein fractional synthesis rate in the postabsorptive and postprandial state, in the presence of tocilizumab as compared to placebo
Measured: 0-21 days
Nutrient uptake
Uptake of fatty acids, glucose and amino acids from a meal in the presence of tocilizumab as compared to placebo
Measured: 0-21 days
Secondary outcomes (28)
Free fatty acids (FFA) (plasma concentration)
Change in postabsorptive and postprandial FFA levels in the presence of tocilizumab as compared to placebo
Measured: 0-21 days
Triglycerides (plasma concentration)
Change in postabsorptive and postprandial triglycerides levels in the presence of tocilizumab as compared to placebo
Measured: 0-21 days
Subjective feeling of hunger and fullness
Hunger and fullness will be assessed on a VAS scale.
Measured: 0-21 days
Insulin (plasma concentration)
Change in postabsorptive and postprandial insulin levels in the presence of tocilizumab as compared to placebo
Measured: 0-21 days
C-peptide (plasma concentration)
Change in postabsorptive and postprandial c-peptide levels in the presence of tocilizumab as compared to placebo
Measured: 0-21 days
Glucagon (plasma concentration)
Change in postabsorptive and postprandial glucagon levels in the presence of tocilizumab as compared to placebo
Measured: 0-21 days
Cortisol (plasma concentration)
Change in postabsorptive and postprandial cortisol levels in the presence of tocilizumab as compared to placebo
Measured: 0-21 days
Adrenaline (plasma concentration)
Change in postabsorptive and postprandial adrenaline levels in the presence of tocilizumab as compared to placebo
Measured: 0-21 days
Noradrenaline (plasma concentration)
Change in postabsorptive and postprandial noradrenaline levels in the presence of tocilizumab as compared to placebo
Measured: 0-21 days
Cytokines, incl. interleukin-6 (IL-6) (plasma concentration)
Change in postabsorptive and postprandial cytokine levels in the presence of tocilizumab as compared to placebo
Measured: 0-21 days
Total and active GLP-1 (plasma concentration)
Change in postabsorptive and postprandial total and active GLP-1 levels in the presence of tocilizumab as compared to placebo
Measured: 0-21 days
GIP (plasma concentration)
Change in postabsorptive and postprandial GIP levels in the presence of tocilizumab as compared to placebo
Measured: 0-21 days
PYY (plasma concentration)
Change in postabsorptive and postprandial PYY postabsorptive and postprandial in the presence of tocilizumab as compared to placebo
Measured: 0-21 days
Leptin (plasma concentration)
Change in postabsorptive and postprandial leptin levels in the presence of tocilizumab as compared to placebo
Measured: 0-21 days
Testosterone (plasma concentration)
Change in postabsorptive testosterone levels in the presence of tocilizumab as compared to placebo
Measured: 0-21 days
TSH (plasma concentration)
Change in postabsorptive TSH levels in the presence of tocilizumab as compared to placebo
Measured: 0-21 days
GH (plasma concentration)
Change in postabsorptive and postprandial GH levels in the presence of tocilizumab as compared to placebo
Measured: 0-21 days
Respiratory exchange ratio (RER)
Indirect calorimetry measured in post-absorptive and postprandial states
Measured: 0-21 days
Femoral artery blood flow
Change in femoral artery blood flow in the presence of tocilizumab as compared to placebo
Measured: 0-21 days
RNA sequencing
RNA sequencing on adipose tissue and skeletal muscle biopsies, monocytes with or without the influence of tocilizumab
Measured: 0-21 days
Mitochondrial respiration (Oroboros)
Mitochondrial respiration in skeletal muscle biopsies with or without the influence of tocilizumab
Measured: 0-21 days
Gastric emptying rate
Gastric emptying rate in the presence of tocilizumab as compared to placebo
Measured: 0-21 days
Plasma metabolome
Plasma metabolome with or without the influence of tocilizumab
Measured: 0-21 days
Plasma, lipidome
Plasma lipidome with or without the influence of tocilizumab
Measured: 0-21 days
Adipose tissue proteome
Adipose tissue proteome with or without the influence of tocilizumab
Measured: 0-21 days
Skeletal muscle proteome
Skeletal muscle proteome with or without the influence of tocilizumab
Measured: 0-21 days
Monocyte secretome
Change in the postabsorptive and postprandial secretory profile of monocytes in the presence of tocilizumab as compared to placebo
Measured: 0-21 days
IL-6 signaling activation in monocytes
IL-6 signaling pathway activation in monocytes from lean participants compared to from obese participants
Measured: 0 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start9 Apr 2021
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- The study is designed in a placebo-controlled crossover manner, consisting of a screening visit and two study visits. Due to the 4-week wash out period of the IL-6 receptor antibody tocilizumab, the order of study visits will be identical in all subjects; hence, study visits will not be randomized. Subjects will be infused with tocilizumab at the end of study visit 1. This will allow us to study the effect of tocilizumab on study visit 2.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helga Ellingsgaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Helga Ellingsgaard, PhD, Principal investigator, CFAS, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687540
- Sponsor's protocol ID
- METO
- Status last verified
- Apr 2022
- First submitted
- 17 Dec 2020
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wallenius V, Wallenius K, Ahren B, Rudling M, Carlsten H, Dickson SL, Ohlsson C, Jansson JO. Interleukin-6-deficient mice develop mature-onset obesity. Nat Med. 2002 Jan;8(1):75-9. doi: 10.1038/nm0102-75.
PubMed 11786910Wueest S, Item F, Boyle CN, Jirkof P, Cesarovic N, Ellingsgaard H, Boni-Schnetzler M, Timper K, Arras M, Donath MY, Lutz TA, Schoenle EJ, Konrad D. Interleukin-6 contributes to early fasting-induced free fatty acid mobilization in mice. Am J Physiol Regul Integr Comp Physiol. 2014 Jun 1;306(11):R861-7. doi: 10.1152/ajpregu.00533.2013. Epub 2014 Apr 2.
PubMed 24694381Wedell-Neergaard AS, Lang Lehrskov L, Christensen RH, Legaard GE, Dorph E, Larsen MK, Launbo N, Fagerlind SR, Seide SK, Nymand S, Ball M, Vinum N, Dahl CN, Henneberg M, Ried-Larsen M, Nybing JD, Christensen R, Rosenmeier JB, Karstoft K, Pedersen BK, Ellingsgaard H, Krogh-Madsen R. Exercise-Induced Changes in Visceral Adipose Tissue Mass Are Regulated by IL-6 Signaling: A Randomized Controlled Trial. Cell Metab. 2019 Apr 2;29(4):844-855.e3. doi: 10.1016/j.cmet.2018.12.007. Epub 2018 Dec 27.
PubMed 30595477Christensen RH, Lehrskov LL, Wedell-Neergaard AS, Legaard GE, Ried-Larsen M, Karstoft K, Krogh-Madsen R, Pedersen BK, Ellingsgaard H, Rosenmeier JB. Aerobic Exercise Induces Cardiac Fat Loss and Alters Cardiac Muscle Mass Through an Interleukin-6 Receptor-Dependent Mechanism: Cardiac Analysis of a Double-Blind Randomized Controlled Clinical Trial in Abdominally Obese Humans. Circulation. 2019 Nov 12;140(20):1684-1686. doi: 10.1161/CIRCULATIONAHA.119.042287. Epub 2019 Nov 11. No abstract available.
PubMed 31710522Petersen EW, Carey AL, Sacchetti M, Steinberg GR, Macaulay SL, Febbraio MA, Pedersen BK. Acute IL-6 treatment increases fatty acid turnover in elderly humans in vivo and in tissue culture in vitro. Am J Physiol Endocrinol Metab. 2005 Jan;288(1):E155-62. doi: 10.1152/ajpendo.00257.2004. Epub 2004 Sep 21.
PubMed 15383370van Hall G, Steensberg A, Sacchetti M, Fischer C, Keller C, Schjerling P, Hiscock N, Moller K, Saltin B, Febbraio MA, Pedersen BK. Interleukin-6 stimulates lipolysis and fat oxidation in humans. J Clin Endocrinol Metab. 2003 Jul;88(7):3005-10. doi: 10.1210/jc.2002-021687.
PubMed 12843134Trinh B, Rasmussen SJ, Brogger-Jensen ME, Engelhard CA, Lund A, Tavanez AR, Vassilieva A, Janum S, Iepsen UW, Kiens B, Moller K, Pedersen BK, Van Hall G, Ellingsgaard H. Inhibition of basal IL-6 activity promotes subcutaneous fat retention in humans during fasting and postprandial states. Cell Rep Med. 2025 Apr 15;6(4):102042. doi: 10.1016/j.xcrm.2025.102042. Epub 2025 Mar 26.
PubMed 40147447
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meal-regulated Substrate Metabolism, Influence of Obesity and IL-6
- ClinicalTrials.gov ID
- NCT04687540
- Acronym / sponsor ID
- METO
- Keywords
- Interleukin-6, Tocilizumab, Postprandial, Postabsorptive, Substrate metabolism, Fat metabolism, Glucose metabolism, Protein metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 29 Dec 2020 (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.
The overall purpose of this explorative yet quantitative study project is to understand how blocking IL-6 signaling leads to the expansion of adipose tissue mass in humans in vivo. The aim is to gain in depth knowledge about how IL-6 receptor blockade affects human lipid, glucose and protein metabolism, specifically the uptake and storage of substrates from a meal vs. their utilization, hence the balance determining whether one gains or loses fat mass.
Detailed description
Lacking IL-6 signaling leads to an expansion of adipose tissue mass in rodents and humans. However, the underlying mechanisms have not been identified.This project aims to investigate the overall hypothesis that IL-6 receptor blockade changes substrate metabolism during postabsorptive and postprandial states to favor storage over mobilization of fat and to favor glucose over fat as a source for energy production. This hypothesis finds some support in the literature: Infusion of recombinant IL-6 into humans, leading to high concentrations of IL-6 in the circulation, stimulates lipolysis and free fatty acid oxidation.
Therefore, the investigators hypothesize that IL-6 receptor blockade impairs the mobilization of FFA from adipose tissue and impairs fat oxidation in skeletal muscle in the postabsorptive state. In the postprandial, state the investigators hypothesize that IL-6 receptor blockade reduces the insulin-induced uptake and deposition of fat by adipose tissue and skeletal muscle, therefore contributing to ectopic fat deposition in the liver.
In this study 12 lean and 12 obese male participants will be included. The participants will attend one screening visit and two study visits. The IL-6 receptor antibody tocilizumab will be infused on study visit 1.
Isotope dilution techniques, blood flow measurements, arterio-venous differences across adipose tissue and skeletal muscle, fat and skeletal muscle biopsies will be used to assess lipid, glucose and protein kinetics on a whole-body as well as fat and skeletal muscle level in the fasting state and after the ingestion of a liquid mixed-meal. Respiratory exchange ratio will be measured by indirect calorimetry.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study is designed in a placebo-controlled crossover manner, consisting of a screening visit and two study visits. Due to the 4-week wash out period of the IL-6 receptor antibody tocilizumab, the order of study visits will be identical in all subjects; hence, study visits will not be randomized. Subjects will be infused with tocilizumab at the end of study visit 1. This will allow us to study the effect of tocilizumab on study visit 2.
| Arm | Type | Receives |
|---|---|---|
| Study day 1 (study visit 1) | Placebo comparator | Drug: TocilizumabBaseline measurements (pre-intervention) are obtained on study visit 1. |
| Study day 21 (study visit 2) | Active comparator | Drug: Saline 0.9%Post-intervention measurements: Participants will be under the influence of tocilizumab, which was injected at the end of study visit 1. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years and ≤ 40 years
- BMI < 18 and > 25 kg/m2
- Healthy (based on screening)
- Stable body weight for 6 months
- Age ≥ 18 years and ≤ 40 years
Key exclusion criteria (4 listed)
- Smoking
- Evidence of severe thyroid or heart disease, inflammatory diseases, current infection, liver disease (transaminases >2x upper normal range), kidney disease (creatinine >1.5 mg/dl), known immunosuppressive disease, corticosteroid use, regular NSAID or paracetamol usage, aspirin use >100 mg/d, history of carcinoma, history of tuberculosis, anemia (hematocrit <33%), WBC <2 x 10^3/ul, platelets <100 x 10^3/ul, bleeding disorders, obstructive pulmonary disease
- Femoral hernia, vascular prosthesis, vascular thrombosis
- Previous nerve damage, many previous femoral catheter installations
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 |
|---|---|---|
| TocilizumabAlso: RoActemraBaseline: Tocilizumab (infusion of 8 mg/kg bodyweight or a maximum of 800 mg) will be infused over 60 minutes at the end for the study day, therefore study visit 1 (study day 1) measurements are baseline. | Drug | Study day 1 (study visit 1) |
| Saline 0.9%Participants are under influence of tocilizumab since the effect of the drug will last for 4 weeks. Participants will be infused with saline at study visit 2 (study day 21). Placebo to tocilizumab will be saline (NaCl 0.9%) as tocilizumab is a colorless solution and has to be diluted with NaCl 0.9% prior to administration | Drug | Study day 21 (study visit 2) |
Primary outcome
Whole-body, fat and skeletal muscle fat turnover
Time frame: 0-21 days
Rate of appearance and disappearance of glycerol and palmitate, fatty acid oxidation and re-esterification, arterio-venous differences of glycerol, palmitate, triglycerides across adipose tissue and skeletal muscle, triglycerides fractional synthesis rate in the postabsorptive and postprandial state in the presence of tocilizumab as compared to placebo
Whole-body, fat and skeletal muscle glucose turnover
Time frame: 0-21 days
Rate of appearance and disappearance of glucose, arterio-venous differences of glucose across adipose tissue and skeletal muscle, glycogen fractional synthesis rate in the postabsorptive and postprandial state in the presence of tocilizumab as compared to placebo
Whole-body, fat and skeletal muscle amino acid and protein turnover
Time frame: 0-21 days
Rate of appearance and disappearance of amino acids, arterio-venous differences of amino acids across adipose tissue and skeletal muscle, protein fractional synthesis rate in the postabsorptive and postprandial state, in the presence of tocilizumab as compared to placebo
Nutrient uptake
Time frame: 0-21 days
Uptake of fatty acids, glucose and amino acids from a meal in the presence of tocilizumab as compared to placebo
28 secondary outcomes
Free fatty acids (FFA) (plasma concentration)
Time frame: 0-21 days
Triglycerides (plasma concentration)
Time frame: 0-21 days
Subjective feeling of hunger and fullness
Time frame: 0-21 days
Insulin (plasma concentration)
Time frame: 0-21 days
C-peptide (plasma concentration)
Time frame: 0-21 days
Glucagon (plasma concentration)
Time frame: 0-21 days
Cortisol (plasma concentration)
Time frame: 0-21 days
Adrenaline (plasma concentration)
Time frame: 0-21 days
Noradrenaline (plasma concentration)
Time frame: 0-21 days
Cytokines, incl. interleukin-6 (IL-6) (plasma concentration)
Time frame: 0-21 days
Total and active GLP-1 (plasma concentration)
Time frame: 0-21 days
GIP (plasma concentration)
Time frame: 0-21 days
PYY (plasma concentration)
Time frame: 0-21 days
Leptin (plasma concentration)
Time frame: 0-21 days
Testosterone (plasma concentration)
Time frame: 0-21 days
TSH (plasma concentration)
Time frame: 0-21 days
GH (plasma concentration)
Time frame: 0-21 days
Respiratory exchange ratio (RER)
Time frame: 0-21 days
Femoral artery blood flow
Time frame: 0-21 days
RNA sequencing
Time frame: 0-21 days
Mitochondrial respiration (Oroboros)
Time frame: 0-21 days
Gastric emptying rate
Time frame: 0-21 days
Plasma metabolome
Time frame: 0-21 days
Plasma, lipidome
Time frame: 0-21 days
Adipose tissue proteome
Time frame: 0-21 days
Skeletal muscle proteome
Time frame: 0-21 days
Monocyte secretome
Time frame: 0-21 days
IL-6 signaling activation in monocytes
Time frame: 0 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Background: PubMed 11786910Wallenius V, Wallenius K, Ahren B, Rudling M, Carlsten H, Dickson SL, Ohlsson C, Jansson JO. Interleukin-6-deficient mice develop mature-onset obesity. Nat Med. 2002 Jan;8(1):75-9. doi: 10.1038/nm0102-75.
- Background: PubMed 24694381Wueest S, Item F, Boyle CN, Jirkof P, Cesarovic N, Ellingsgaard H, Boni-Schnetzler M, Timper K, Arras M, Donath MY, Lutz TA, Schoenle EJ, Konrad D. Interleukin-6 contributes to early fasting-induced free fatty acid mobilization in mice. Am J Physiol Regul Integr Comp Physiol. 2014 Jun 1;306(11):R861-7. doi: 10.1152/ajpregu.00533.2013. Epub 2014 Apr 2.
- Background: PubMed 30595477Wedell-Neergaard AS, Lang Lehrskov L, Christensen RH, Legaard GE, Dorph E, Larsen MK, Launbo N, Fagerlind SR, Seide SK, Nymand S, Ball M, Vinum N, Dahl CN, Henneberg M, Ried-Larsen M, Nybing JD, Christensen R, Rosenmeier JB, Karstoft K, Pedersen BK, Ellingsgaard H, Krogh-Madsen R. Exercise-Induced Changes in Visceral Adipose Tissue Mass Are Regulated by IL-6 Signaling: A Randomized Controlled Trial. Cell Metab. 2019 Apr 2;29(4):844-855.e3. doi: 10.1016/j.cmet.2018.12.007. Epub 2018 Dec 27.
- Background: PubMed 31710522Christensen RH, Lehrskov LL, Wedell-Neergaard AS, Legaard GE, Ried-Larsen M, Karstoft K, Krogh-Madsen R, Pedersen BK, Ellingsgaard H, Rosenmeier JB. Aerobic Exercise Induces Cardiac Fat Loss and Alters Cardiac Muscle Mass Through an Interleukin-6 Receptor-Dependent Mechanism: Cardiac Analysis of a Double-Blind Randomized Controlled Clinical Trial in Abdominally Obese Humans. Circulation. 2019 Nov 12;140(20):1684-1686. doi: 10.1161/CIRCULATIONAHA.119.042287. Epub 2019 Nov 11. No abstract available.
- Background: PubMed 15383370Petersen EW, Carey AL, Sacchetti M, Steinberg GR, Macaulay SL, Febbraio MA, Pedersen BK. Acute IL-6 treatment increases fatty acid turnover in elderly humans in vivo and in tissue culture in vitro. Am J Physiol Endocrinol Metab. 2005 Jan;288(1):E155-62. doi: 10.1152/ajpendo.00257.2004. Epub 2004 Sep 21.
- Background: PubMed 12843134van Hall G, Steensberg A, Sacchetti M, Fischer C, Keller C, Schjerling P, Hiscock N, Moller K, Saltin B, Febbraio MA, Pedersen BK. Interleukin-6 stimulates lipolysis and fat oxidation in humans. J Clin Endocrinol Metab. 2003 Jul;88(7):3005-10. doi: 10.1210/jc.2002-021687.
- Derived from this study: PubMed 40147447Trinh B, Rasmussen SJ, Brogger-Jensen ME, Engelhard CA, Lund A, Tavanez AR, Vassilieva A, Janum S, Iepsen UW, Kiens B, Moller K, Pedersen BK, Van Hall G, Ellingsgaard H. Inhibition of basal IL-6 activity promotes subcutaneous fat retention in humans during fasting and postprandial states. Cell Rep Med. 2025 Apr 15;6(4):102042. doi: 10.1016/j.xcrm.2025.102042. Epub 2025 Mar 26.
- 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. This study is not recruiting at the moment.
Helga Ellingsgaard, PhD principal investigator
CFAS, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tocilizumab and Saline 0.9% in people with Obesity and Healthy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 10 inclusion and 4 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: finished, as of the sponsor's last update on 15 Apr 2022. 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 Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole-body, fat and skeletal muscle fat turnover (time frame: 0-21 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04687540, which also lists 7 linked publications.
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 15 Apr 2022.