Recruiting
Phase 2
Phase 3

Intranasal Glucagon

Sponsor:

University Health Network, Toronto

Code:

NCT03650582

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Glucagon

Placebo

Study Details

Brief summary:

People who are overweight often find it difficult to lose weight through diet and medications because weight loss reduces the amount of energy spent by the body and increases appetite. Glucagon, when given as an injection, reduces appetite and increases the amount of energy spent by the body, even when resting. Based on studies in animals, it does so by working on the brain. However, when gives as an injection it raises blood sugar levels by acting on the liver and therefore it is not used as a weight loss drug. It has previously been shown that hormones such as glucagon, when given as a spray through the nose, can reach the brain with no major effect on the liver. Importantly it does not increase blood sugar. In this study the research team is investigating whether nasal glucagon reduces appetite and increases energy spent by the body compared to a placebo spray. If it does, it may be a potential treatment for losing weight.

Conditions

Obesity

Study ID

NCT03650582

Start date

Jun 6, 2017

Status verified date

Feb, 2018

Completion date

Oct 30, 2018

Anticipated

Primary completion date

Sep 30, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Body mass index 25- 40 kg/m2
  • Hemoglobin in the normal range
  • Normal fasting glucose and HbA1C
  • Women of reproductive age should be on contraception (oral contraceptive pill or intra-uterine device/coil) for at least 1 month prior to and after the study.

Exclusion Criteria:

  • Any history of heart disease or clinically significant, active, cardiovascular history
  • Study participant with active hepatic disease (except hepatic steatosis which is frequently seen in overweight/obese individuals)
  • Any current or previous history of biliary disease (including gall stones, biliary atresia and cholecystitis) or pancreatitis.
  • Any current or previous history of malignancy
  • Any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (Cr > 1.5 mg/dL) genitourinary, hematological systems, or has severe uncontrolled treated or untreated hyper/ hypotension (sitting diastolic BP > 100 or systolic > 180 or systolic BP<100).
  • Allergy to any study medication
  • Pregnancy or breastfeeding

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Glucagon

Glucagon, 0.7mg, intranasal, single dose

placebo comparator: Placebo

Placebo, intranasal, single dose

Interventions

Glucagon

Intranasal glucagon

Placebo

Intranasal placebo

Primary outcome measure

  • Energy Expenditure [ Time Frame: 90 minutes ]

Central Contacts and Locations

Central contacts

Locations

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

More Information

Sponsor

University Health Network, Toronto

Last update posted

Aug 31, 2018

Last verified

Feb, 2018

Keywords

  • food intake
  • energy expenditure
  • central nervous system
  • appetite

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2018-08-31.