ObesityPhase 2/3INGEBNCT03650582
Intranasal Glucagon and Energy Balance
A Phase 2/3 study testing Glucagon in people with Obesity, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Glucagon
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 6 Jun 2017to 30 Oct 2018
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Priska Stahel, PhD, 415-581-7487, priska.stahel@uhn.ca
Satya Dash, MD, 416-340-4800 ext. 8094, satya.dash@uhn.ca
About this study
Official title: Assessing the Effects of Intranasal Glucagon on Energy Balance in Humans
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.
Read the detailed description
Resting energy expenditure, appetite and food intake is being investigated in up to 20 individuals. Participants are their own control in a single-blind, placebo-controlled, crossover design. Participants are admitted after an overnight fast and allowed to rest for 1 hour before either intranasal glucagon (0.7mg) or intranasal placebo (sterile diluent) is administered. Study visits occur 1-3 weeks apart with intranasal glucagon or placebo applied in random order. Resting energy expenditure is measured via indirect calorimetry at baseline and over 90 minutes post-spray in 10-20 minute segments. Blood samples are taken at baseline and at regular intervals post-spray to measure glucagon, glucose and other hormones/metabolites. Appetite is assessed by visual analogue scale at 90 minutes post-spray followed by provision of a buffet-style meal for ad libitum food intake measurement.
- Conditions
- Obesity
- Being tested
- Glucagon, Placebo
- Keywords
- food intake, energy expenditure, central nervous system, appetite
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucagonDrug
Intranasal glucagon
PlaceboDrug
Intranasal placebo
| Study group | Role | What they receive |
|---|---|---|
| Glucagon | Experimental | Glucagon, 0.7mg, intranasal, single dose Receives: Drug: Glucagon |
| Placebo | Placebo comparator | Placebo, intranasal, single dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy Expenditure
Resting energy expenditure measured by indirect calorimetry
Measured: 90 minutes
Secondary outcomes (2)
Food intake
Ad libitum food intake
Measured: 90 minutes
Appetite
Appetite assessed by visual analogue scale ranging from 0 to 10 where 0 indicates no appetite and 10 indicates the highest appetite
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start6 Jun 2017
- Primary completion30 Sep 2018 (estimated)
- Study completion30 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 2/3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants receive either glucagon or placebo as intranasal spray, in random order on 2 separate study visits, with indirect calorimetry, appetite and food intake assessment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Satya Dash, MD, Principal investigator, UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650582
- Sponsor's protocol ID
- ING 16-5909
- Acronym
- INGEB
- Status last verified
- Feb 2018
- First submitted
- 27 Feb 2018
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effects of Intranasal Glucagon on Energy Balance in Humans
- ClinicalTrials.gov ID
- NCT03650582
- Acronym / sponsor ID
- INGEB / ING 16-5909
- Conditions
- Obesity
- Keywords
- food intake, energy expenditure, central nervous system, appetite
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 30 Oct 2018 (estimated)
- First posted
- 28 Aug 2018 (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.
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.
Detailed description
Resting energy expenditure, appetite and food intake is being investigated in up to 20 individuals. Participants are their own control in a single-blind, placebo-controlled, crossover design. Participants are admitted after an overnight fast and allowed to rest for 1 hour before either intranasal glucagon (0.7mg) or intranasal placebo (sterile diluent) is administered. Study visits occur 1-3 weeks apart with intranasal glucagon or placebo applied in random order. Resting energy expenditure is measured via indirect calorimetry at baseline and over 90 minutes post-spray in 10-20 minute segments. Blood samples are taken at baseline and at regular intervals post-spray to measure glucagon, glucose and other hormones/metabolites. Appetite is assessed by visual analogue scale at 90 minutes post-spray followed by provision of a buffet-style meal for ad libitum food intake measurement.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants receive either glucagon or placebo as intranasal spray, in random order on 2 separate study visits, with indirect calorimetry, appetite and food intake assessment
| Arm | Type | Receives |
|---|---|---|
| Glucagon | Experimental | Drug: GlucagonGlucagon, 0.7mg, intranasal, single dose |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, intranasal, single dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
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 |
|---|---|---|
| GlucagonIntranasal glucagon | Drug | Glucagon |
| PlaceboIntranasal placebo | Drug | Placebo |
Primary outcome
Energy Expenditure
Time frame: 90 minutes
Resting energy expenditure measured by indirect calorimetry
2 secondary outcomes
Food intake
Time frame: 90 minutes
Appetite
Time frame: 90 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- 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.
Satya Dash, MD principal investigator
UHN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Glucagon in people with Obesity, run by University Health Network, Toronto at 1 site in Canada.
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 7 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: status not confirmed, as of the sponsor's last update on 31 Aug 2018. 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 Canada. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Priska Stahel, PhD (416-581-7487, priska.stahel@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy Expenditure (time frame: 90 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 31 Aug 2018.