Defining the Glucagon Unit: Investigating the Impact on Energy Expenditure and Glucose Level Deviation in healthy volunteers

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Pauls Stradins Clinical University Hospital

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

1 Jun 2025 → 1 Jun 2025

Decision date (initial)

2024-06-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

University of Latvia (VPP-EM-BIOMEDICĪNA-2022/1-0001)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

The primary objective of this study is to define the glucagon unit by investigating its
impact on energy expenditure, glucose level deviation in the presence and absence of
incretin-stimulated insulin secretion, and comparing the results with intravenous (i/v)
and oral (p/o) glucose uptake.

Secondary objectives 1

1. ...

Conditions and MedDRA coding

Obesity

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Age 18 - 40 years.
2. Male sex
3. BMI 25 - 34.9.
4. Signed informed consent

Exclusion criteria 12

1. Not signed informed consent
2. Any other medical condition or treatment that, in the opinion of the investigator, would interfere with the study objectives, conduct, or interpretation of results.
3. Inability to tolerate calorimeter canopy.
4. Participants who have received any investigational product or medication within 180 days prior to screening.
5. Participants who have donated blood or plasma within 30 days prior to screening.
6. Participants who have a known allergy or intolerance to any of the study medications or their components.
7. Inability to comply with study requirements
8. BMI > 35 kg/m2 and < 25 kg/m2
9. History of gastrointestinal disorders, surgery or other medical conditions that could affect nutrient absorption and/or predispose a subject to side effects of GLP-RA (chronic pancreatitis, dysmotility, rapidly growing thyroid nodules etc)
10. Abnormal laboratory results: ○ TSH < 0,4 or > 4,0 mIU/L ○ ALAT > 40 U/L ○ CKD (GFR < 90 ml/min/m2) ○ Abnormal fasting glucose (≥6.1 mmol/L) ○ abnormal HbA1c (≥5.7%) ○ Other significant deviations according to research team views
11. Diabetes mellitus (any type).
12. Current use of any anti-diabetic drugs (for any indication).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline in resting energy expenditure (EE) measured by indirect calorimetry after intervention with glucose, intravenous glucose, intravenous glucagon, semaglutide, saline, and additional glucagon infusion.

Secondary endpoints 8

1. Change from baseline in respiratory quotient (RQ) measured by indirect calorimetry after intervention with glucose, intravenous glucose, intravenous glucagon, semaglutide, saline, and additional glucagon infusion.
2. Change from baseline in carbohydrate oxidation rates measured by indirect calorimetry after intervention with glucose, intravenous glucose, intravenous glucagon, semaglutide, saline, and additional glucagon infusion.
3. Change from baseline in fat oxidation rates measured by indirect calorimetry after intervention with glucose, intravenous glucose, intravenous glucagon, semaglutide, saline, and additional glucagon infusion.
4. Changes in blood levels of insulin, glucose, GLP-1, and glucagon at predetermined intervals after intervention with glucose, intravenous glucose, intravenous glucagon, semaglutide, saline, and additional glucagon infusion.
5. Side effects reported during the self-observation weeks after each intervention.
6. Body weight changes throughout the study period, including before and after each intervention.
7. Comparison of postprandial glucose excursion between different interventions, measured by continuous glucose monitoring (CGM).
8. Assessment of changes in urinary nitrogen excretion as a measure of protein metabolism in response to interventions.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pauls Stradins Clinical University Hospital

Sponsor organisation

Pauls Stradins Clinical University Hospital

Address

Pilsonu Iela 13

City

Riga

Postcode

1002

Country

Latvia

Scientific contact point

Organisation

Pauls Stradins Clinical University Hospital

Contact name

Svjatoslavs Kistkins

Public contact point

Organisation

Pauls Stradins Clinical University Hospital

Contact name

Valdis Pīrāgs

Sponsor responsibilities

Article 77 compliance

Pauls Stradins Clinical University Hospital

Contact point sponsor

Pauls Stradins Clinical University Hospital

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Layperson summary Annex V

Documents 1 file

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications