HealthyIGLUNCT06721910
Interplay Between Interleukin-6 and Glucagon in the Regulation of Human Amino Acid and Protein Homeostasis
A study testing Tocilizumab in people with Healthy and Glucagon Resistance, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The goal of this proof-of-concept study is to learn if interleukin-6 changes the effect of glucagon in healthy volunteers. The main question it aims to answer is: Does IL-6 influence how effectively glucagon lowers the concentration of amino acids in blood? Researchers will compare the infusion of normal saline and a… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Glucagon Resistance, Amino Acid Change
- What is being tested?
- Tocilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Jan 2025to 18 Sep 2025
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 50 years
- BMI 18.5 - 25 kg/m2
- Stable body weight in the past 6 months before study initiation
- Women should be anovulatory on non-cyclic hormone replacement or hormonal contraception
Who cannot join
- Previous medical history for any chronic condition in the last three months, active disease or abnormal physical examination as verified by a qualified physician
- Body weight unstable in the past 6 months
- Use of tobacco/nicotine
- Alcohol consumption >30g/day
- Participation in an investigational drug trial within the past two months
- Current intake of any drugs (prescribed, over the counter or recreational)
Show all 9Show fewer
- Known allergy to tocilizumab
- Pregnant or lactating women,
- Inability or unwillingness to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this proof-of-concept study is to learn if interleukin-6 changes the effect of glucagon in healthy volunteers. The main question it aims to answer is:
Does IL-6 influence how effectively glucagon lowers the concentration of amino acids in blood? Researchers will compare the infusion of normal saline and a blocker of the receptor for interleukin-6 to see if blocking interluekin-6 changes how effectively glucagon lowers the concentration of amino acids in blood.
Read more
Participants will be asked to
- receive either an infusion of normal saline or the interleukin-6 receptor blocker
- participate in a study visit three weeks later at which they will receive infusions of hormones and amino acids to mimic the concentrations of the hormones insulin and glucagon during fasting or fed conditions
- labelled glucose, glycerol and amino acids will also be infused continuously to track the fate of these molecules
- during the hormone infusions blood samples will be taken repeatedly
- Conditions
- Healthy, Glucagon Resistance, Amino Acid Change
- Being tested
- Tocilizumab, Placebo
- Keywords
- interleukin-6, gluagon, pancreatic clamp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
Blockade of the interleukin-6 receptor
PlaceboOther
Infusion of 100 ml normal saline
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Infusion of 100 ml normal saline Receives: Other: Placebo |
| IL-6R ab | Active comparator | Infusion of tocilizumab, 8mg/kg body weight or max. 800mg in 100 ml normal saline Receives: Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximum glucagon-induced reduction in total plasma amino acid concentrations
Measured: At visit 2 during high glucagon phase (80-120 minutes)
Secondary outcomes (18)
AUC of total amino acids
Measured: At visit 2 during high glucagon phase (80-120 minutes)
rate of phenylalanine oxidation
Measured: At visit 2 (15, 30, 45, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes)
urea concentrations
Measured: At visit 2 (15, 30, 45, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes)
rate of gluconeogenesis from amino acids
Measured: At visit 2 (15, 30, 45, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes)
fractional synthesis rate of plasma proteins
Measured: At visit 2 (60, 180, 300 minutes)
Amino acid uptake by PBMCs ex vivo
Measured: At visit 1 and visit 2 (-120 minutes)
Change in fractional synthesis rate of lipoproteins
Measured: At visit 2 (60, 180, 300 minutes)
Cytokine plasma concentrations (IL-6, IL-1RA, TNF-alpha, IL-8, IL-10, CRP)
Measured: At visit 2 (15, 30, 45, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes)
Plasma concentrations of insulin, c-peptide, glucagon, GH, IGF-1, cortisol, catecholamines, fT4, fT3, FGF21, follistatin, AGPTL4, ketones
Measured: At visit 2 (15, 30, 45, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes)
Energy expenditure kcal/24 hours
Measured: At visit 2 (40, 160, 280 minutes)
Respiratory exchange rate
Measured: At visit 2 (40, 160, 280 minutes)
Oxygen consumption (VO2 ml/minutes)
Measured: At visit 2 (40, 160, 280 minutes)
Carbondioxid production (VCO2 ml/minutes)
Measured: At visit 2 (40, 160, 280 minutes)
Body composition (lean body mass kg)
Measured: At visit 1 and 2 (-120 minutes)
Body composition (fat bodymass kg)
Measured: At visit 1 and 2 (-120 minutes)
Blood pressure systolic
Measured: At visit 2 (-120 minutes)
Blood pressure diastolic
Measured: At visit 2 (-120 minutes)
Heart rate
Measured: At visit 2 (-120minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start15 Jan 2025
- Primary completion18 Sep 2025
- Study completion18 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, parallel
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beckey Trinh, MD, PhD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721910
- Sponsor's protocol ID
- IGLU
- Acronym
- IGLU
- Status last verified
- Sep 2025
- First submitted
- 30 Mar 2024
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interplay Between Interleukin-6 and Glucagon in the Regulation of Human Amino Acid and Protein Homeostasis
- ClinicalTrials.gov ID
- NCT06721910
- Acronym / sponsor ID
- IGLU / IGLU
- Conditions
- Healthy, Glucagon Resistance, Amino Acid Change
- Keywords
- interleukin-6, gluagon, pancreatic clamp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 18 Sep 2025 (actual)
- Study completion
- 18 Sep 2025 (actual)
- First posted
- 6 Dec 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.
The goal of this proof-of-concept study is to learn if interleukin-6 changes the effect of glucagon in healthy volunteers. The main question it aims to answer is:
Does IL-6 influence how effectively glucagon lowers the concentration of amino acids in blood? Researchers will compare the infusion of normal saline and a blocker of the receptor for interleukin-6 to see if blocking interluekin-6 changes how effectively glucagon lowers the concentration of amino acids in blood.
Participants will be asked to
- receive either an infusion of normal saline or the interleukin-6 receptor blocker
- participate in a study visit three weeks later at which they will receive infusions of hormones and amino acids to mimic the concentrations of the hormones insulin and glucagon during fasting or fed conditions
- labelled glucose, glycerol and amino acids will also be infused continuously to track the fate of these molecules
- during the hormone infusions blood samples will be taken repeatedly
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, parallel
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboInfusion of 100 ml normal saline |
| IL-6R ab | Active comparator | Drug: TocilizumabInfusion of tocilizumab, 8mg/kg body weight or max. 800mg in 100 ml normal saline |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18 to 50 years
- BMI 18.5 - 25 kg/m2
- Stable body weight in the past 6 months before study initiation
- Women should be anovulatory on non-cyclic hormone replacement or hormonal contraception
Key exclusion criteria (9 listed)
- Previous medical history for any chronic condition in the last three months, active disease or abnormal physical examination as verified by a qualified physician
- Body weight unstable in the past 6 months
- Use of tobacco/nicotine
- Alcohol consumption >30g/day
- Participation in an investigational drug trial within the past two months
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 |
|---|---|---|
| TocilizumabBlockade of the interleukin-6 receptor | Drug | IL-6R ab |
| PlaceboInfusion of 100 ml normal saline | Other | Placebo |
Primary outcome
Change in maximum glucagon-induced reduction in total plasma amino acid concentrations
Time frame: At visit 2 during high glucagon phase (80-120 minutes)
18 secondary outcomes
AUC of total amino acids
Time frame: At visit 2 during high glucagon phase (80-120 minutes)
rate of phenylalanine oxidation
Time frame: At visit 2 (15, 30, 45, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes)
urea concentrations
Time frame: At visit 2 (15, 30, 45, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes)
rate of gluconeogenesis from amino acids
Time frame: At visit 2 (15, 30, 45, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes)
fractional synthesis rate of plasma proteins
Time frame: At visit 2 (60, 180, 300 minutes)
Amino acid uptake by PBMCs ex vivo
Time frame: At visit 1 and visit 2 (-120 minutes)
Change in fractional synthesis rate of lipoproteins
Time frame: At visit 2 (60, 180, 300 minutes)
Cytokine plasma concentrations (IL-6, IL-1RA, TNF-alpha, IL-8, IL-10, CRP)
Time frame: At visit 2 (15, 30, 45, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes)
Plasma concentrations of insulin, c-peptide, glucagon, GH, IGF-1, cortisol, catecholamines, fT4, fT3, FGF21, follistatin, AGPTL4, ketones
Time frame: At visit 2 (15, 30, 45, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes)
Energy expenditure kcal/24 hours
Time frame: At visit 2 (40, 160, 280 minutes)
Respiratory exchange rate
Time frame: At visit 2 (40, 160, 280 minutes)
Oxygen consumption (VO2 ml/minutes)
Time frame: At visit 2 (40, 160, 280 minutes)
Carbondioxid production (VCO2 ml/minutes)
Time frame: At visit 2 (40, 160, 280 minutes)
Body composition (lean body mass kg)
Time frame: At visit 1 and 2 (-120 minutes)
Body composition (fat bodymass kg)
Time frame: At visit 1 and 2 (-120 minutes)
Blood pressure systolic
Time frame: At visit 2 (-120 minutes)
Blood pressure diastolic
Time frame: At visit 2 (-120 minutes)
Heart rate
Time frame: At visit 2 (-120minutes)
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 3 Oct 2025.
- 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.
Beckey Trinh, MD, PhD principal investigator
University Hospital, Basel, Switzerland
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 in people with Healthy and Glucagon Resistance, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 4 inclusion and 9 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 3 Oct 2025. 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 Switzerland. 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?
Change in maximum glucagon-induced reduction in total plasma amino acid concentrations (time frame: At visit 2 during high glucagon phase (80-120 minutes)). 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 3 Oct 2025.