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ObesityPhase 1GIONCT02817659

To Determine Tolerability to Glucagon Infusion in Obese Subjects

A Phase 1 study testing Glucagon in people with Obesity, run by AdventHealth Translational Research Institute at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

To further understand the tolerability of glucagon. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Glucagon
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
1 Nov 2016to Dec 2026
Phase
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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age 18-55 years, inclusive
  • BMI ≥27 to ≤40 kg/m2
  • Stable body weight for 3 months (self-reported loss/gain <5%)
  • Subject is judged to be non-diabetic and in good health on the basis of medical history, physical examination, electrocardiogram, and routine laboratory data
  • Subject understands the procedures and agrees to participate in the study program by giving written informed consent, and is willing to comply with the trial restrictions
  • Subject is willing to avoid alcohol consumption for 48 hours prior to the inpatient study visit
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  • Subject is willing to avoid consumption of caffeine and caffeinated beverages for 24 hours prior to the inpatient study visit
  • Subject is willing to avoid strenuous physical activity for 72 hours prior to the inpatient study visit
  • Female subjects of child bearing potential must be willing to use acceptable birth control during study participation (oral contraceptives, intrauterine device, implanted or injectable contraceptives, abstinence).

Who cannot join

  • Treatment with any medication known to significantly impact body weight (e.g., weight loss medications, atypical antipsychotics) within 3 months prior to screening except for stable physiological hormone replacement therapy (i.e., thyroid hormone, estrogen)
  • History of bariatric surgery
  • Current liver, renal, pulmonary, cardiac, oncologic, metabolic, gastrointestinal or hematologic disease which the Investigator believes is clinically significant, including:
  • Liver disease or liver injury as indicated by abnormal liver function tests (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase , serum bilirubin) >3 × upper limit of normal (ULN), or history of hepatic cirrhosis
  • History or presence of impaired renal function as indicated by an estimated glomerular filtration rate <60 ml/hr or urine albumin-to-creatinine ratio >35 mg/mmol
  • Significant cardiovascular disease, including Class III or greater congestive heart failure (CHF), coronary artery disease, second degree or greater heart block, or clinically significant arrhythmias; baseline second degree or greater heart block or prolonged QT syndrome (QTc interval ≥ 470 msec); or any major cardiovascular event within the last 3 years (including myocardial infarction, transient ischemic attack [TIA], cerebrovascular accident [CVA], angina, and hospitalization due to CHF, transient ischemic attack (TIA), and CVA)
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  • Metabolic, other or endocrine disorders, including diagnosis of type 1 or type 2 diabetes mellitus [HbA1c ≥6.5%]), inadequately treated hyperthyroidism (thyroid stimulating hormone [TSH] below normal range) or hypothyroidism (TSH above upper limit of normal if symptomatic or TSH >10 U/mL), Cushing syndrome, Addison's disease, hypogonadism, or genetic disorders linked to obesity
  • History of irritable bowel disease, recurrent nausea or vomiting
  • Anemia (hemoglobin <12 g/dl in men, <11 g/dl in women)
  • Self-reported history of hepatitis B, hepatitis C, or HIV
  • History of recurrent sleep disturbances and/or prone to sleep disturbances based on lifestyle or employment (e.g., variable work schedule, overnight shift work, etc.)
  • Diagnosis of sleep apnea with or without use of (continuous positive airway pressure)
  • Major surgery within last 3 months
  • Blood donation within 4 weeks prior to the screening visit
  • Participation in another investigational trial within 4 weeks prior to the screening visit. The 4 week window will be derived from the date of the last trial medication and/or blood collection in a previous trial and/or adverse event (AE) related to trial drug to the screening visit of the current trial.
  • Illicit drug abuse or use of nicotine-containing products within 3 months prior to the screening visit
  • Poor intravenous access
  • Blood pressure less than 100/50 mm Hg or greater than or equal to 160/100 mm Hg at screening visit
  • Heart rate greater than or equal to 100 beats/min at screening visit
  • Fasting plasma glucose <60 mg/dL or ≥126 mg/dL at screening visit
  • Translational Research Institute (TRI) staff member or immediate relative of TRI staff member, directly involved with this study
  • History of any illness or condition that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by study participation

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Translational Research Institute for Metabolism and Diabetes

    Orlando, Florida, 32804

Other trials in United States

About this study

Official title: A Pilot Study to Determine Tolerability to Glucagon Infusion in Obese Subjects

To further understand the tolerability of glucagon.

Read the detailed description

To determine the tolerability of glucagon infusion administered in an escalating step-wise manner in healthy obese subjects

Conditions
Obesity
Being tested
Glucagon
Keywords
Glucagon
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GlucagonDrug

    Glucagon infusion

Study groups in NCT02817659
Study groupRoleWhat they receive
Glucagon InfusionExperimentalGlucagon infusion in escalating manner at 12.5, 25, 37.5 and 50 ng/kg/min (each step for 60 min). At 30 and 60 mins of each infusion rate, we will administer a previously established questionnaire to assess overall nausea intensity.
Receives: Drug: Glucagon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measure glucagon tolerance in healthy obese subject prior to subject becoming significantly nauseous.

    Glucagon infused in escalating manner. Each dose administered for 60 minutes. Intensity of nausea measured by administering a questionnaire that measures overall nausea intensity.

    Measured: Visit 1, measured at 30 minutes

  2. Measure glucagon tolerance in healthy obese subject prior to subject becoming significantly nauseous.

    Glucagon infused in escalating manner. Each dose administered for 60 minutes. Intensity of nausea measured by administering a questionnaire that measures overall nausea intensity.

    Measured: Visit 1, measured at 60 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2016 (estimated)
  2. Study start1 Nov 2016
  3. Primary completion13 Jan 2017
  4. Study completionDec 2026 (estimated)

Resources

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 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02817659
Sponsor's protocol ID
TRIMDFH 778967
Acronym
GIO
Status last verified
Mar 2026
First submitted
8 Jun 2016
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Astrup A, Rossner S, Van Gaal L, Rissanen A, Niskanen L, Al Hakim M, Madsen J, Rasmussen MF, Lean ME; NN8022-1807 Study Group. Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study. Lancet. 2009 Nov 7;374(9701):1606-16. doi: 10.1016/S0140-6736(09)61375-1. Epub 2009 Oct 23.

    PubMed 19853906

  • Flint A, Raben A, Rehfeld JF, Holst JJ, Astrup A. The effect of glucagon-like peptide-1 on energy expenditure and substrate metabolism in humans. Int J Obes Relat Metab Disord. 2000 Mar;24(3):288-98. doi: 10.1038/sj.ijo.0801126.

    PubMed 10757621

  • Cryer PE. Minireview: Glucagon in the pathogenesis of hypoglycemia and hyperglycemia in diabetes. Endocrinology. 2012 Mar;153(3):1039-48. doi: 10.1210/en.2011-1499. Epub 2011 Dec 13.

    PubMed 22166985

  • SCHULMAN JL, CARLETON JL, WHITNEY G, WHITEHORN JC. Effect of glucagon on food intake and body weight in man. J Appl Physiol. 1957 Nov;11(3):419-21. doi: 10.1152/jappl.1957.11.3.419. No abstract available.

    PubMed 13480952

  • Nair KS. Hyperglucagonemia increases resting metabolic rate in man during insulin deficiency. J Clin Endocrinol Metab. 1987 May;64(5):896-901. doi: 10.1210/jcem-64-5-896.

    PubMed 2881943

  • Calles-Escandon J. Insulin dissociates hepatic glucose cycling and glucagon-induced thermogenesis in man. Metabolism. 1994 Aug;43(8):1000-5. doi: 10.1016/0026-0495(94)90180-5.

    PubMed 8052138

  • Salem V, Izzi-Engbeaya C, Coello C, Thomas DB, Chambers ES, Comninos AN, Buckley A, Win Z, Al-Nahhas A, Rabiner EA, Gunn RN, Budge H, Symonds ME, Bloom SR, Tan TM, Dhillo WS. Glucagon increases energy expenditure independently of brown adipose tissue activation in humans. Diabetes Obes Metab. 2016 Jan;18(1):72-81. doi: 10.1111/dom.12585. Epub 2015 Nov 20.

    PubMed 26434748

  • Melzack R, Rosberger Z, Hollingsworth ML, Thirlwell M. New approaches to measuring nausea. CMAJ. 1985 Oct 15;133(8):755-8, 761.

    PubMed 4042058

  • Tan TM, Field BC, McCullough KA, Troke RC, Chambers ES, Salem V, Gonzalez Maffe J, Baynes KC, De Silva A, Viardot A, Alsafi A, Frost GS, Ghatei MA, Bloom SR. Coadministration of glucagon-like peptide-1 during glucagon infusion in humans results in increased energy expenditure and amelioration of hyperglycemia. Diabetes. 2013 Apr;62(4):1131-8. doi: 10.2337/db12-0797. Epub 2012 Dec 17.

    PubMed 23248172

  • Miyoshi H, Shulman GI, Peters EJ, Wolfe MH, Elahi D, Wolfe RR. Hormonal control of substrate cycling in humans. J Clin Invest. 1988 May;81(5):1545-55. doi: 10.1172/JCI113487.

    PubMed 3284915

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Glucagon in people with Obesity, run by AdventHealth Translational Research Institute 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 9 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 30 Mar 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

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?

Measure glucagon tolerance in healthy obese subject prior to subject becoming significantly nauseous. (time frame: Visit 1, measured at 30 minutes). 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?

On the ClinicalTrials.gov record for NCT02817659, which also lists 10 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 30 Mar 2026.

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