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Last Updated: February 15, 2025

CLINICAL TRIALS PROFILE FOR GLUCAGON


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505(b)(2) Clinical Trials for Glucagon

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT04520490 ↗ Brain Activation and Satiety in Children 2 Recruiting University of Washington Phase 3 2021-01-28 Childhood obesity and related long-term effects are serious public health problems, but not all children with obesity do well in treatment. This study will test a new combination of family-based behavioral treatment (FBT) with a drug intervention using a glucagon-like peptide-1 receptor agonist (GLP-1RA) exenatide once weekly extended-release (ExQW, Bydureon®) in order to improve obesity intervention outcomes in 10-12-year-old children.
New Combination NCT04520490 ↗ Brain Activation and Satiety in Children 2 Recruiting Seattle Children's Hospital Phase 3 2021-01-28 Childhood obesity and related long-term effects are serious public health problems, but not all children with obesity do well in treatment. This study will test a new combination of family-based behavioral treatment (FBT) with a drug intervention using a glucagon-like peptide-1 receptor agonist (GLP-1RA) exenatide once weekly extended-release (ExQW, Bydureon®) in order to improve obesity intervention outcomes in 10-12-year-old children.
New Formulation NCT05206149 ↗ Stimulation Test With Intranasal Glucagon for Corticotroph, Somatotroph and Antidiuretic Axes Completed Azienda Ospedaliera Città della Salute e della Scienza di Torino Phase 4 2021-10-01 The diagnosis of secondary hypoadrenalism and GH deficiency (GHD) often requires the performance of a dynamic test. The glucagon stimulation test (GST) is one of the options for evaluating hypothalamic-pituitary function, representing a stimulus for both the corticotropic and somatotropic axis, substantially safe and easily available. The standard procedure involves the intramuscular injection of 1-1.5 mg of glucagon based on the patient's weight. In addition to its antero-pituitary function, glucagon has also shown its ability to stimulate neurohypophyseal secretion. Using the copeptin dosage, it has been shown that after the administration of glucagon in healthy subjects there is a significant release of ADH. However, the available data are scarse and there is no standardized protocol for the use of the glucagon test in diabetes insipidus. At the moment, GST is not the most frequently chosen diagnostic option. In fact, despite having the advantage of being able to investigate different areas of anterohypophyseal and probably posterohypophyseal function at the same time, the test has some disadvantages: the prolonged duration makes the procedure challenging, the intramuscular injection can be unwelcome, and many variables can come into play in the definition of a normal response (age, BMI, glycemic status). The recent introduction of a single-dose nasal powder formulation (Baqsimi®) could overcome some of the limitations of classic GST and make the procedure less demanding. To date, no assessments are yet available regarding a purely diagnostic role in the context of hypopituitarism of this new formulation. Through the knowledge of the physiological response of the adrenocortical, somatotropic and ADH axis to the administration of intranasal glucagon in healthy subjects, it will be possible to evaluate its possible application in the diagnosis of GH deficiency, central adrenal insufficiency and possibly diabetes insipidus.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Glucagon

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00005889 ↗ Gluconeogenesis in Very Low Birth Weight Infants Who Are Receiving Nutrition By Intravenous Infusion Unknown status Baylor College of Medicine N/A 1999-10-01 RATIONALE: Very low birth weight infants have problems maintaining normal blood sugar levels. Gluconeogenesis is the production of sugar from amino acids and fats. The best combination of amino acids, fat, and sugar to help very low birth weigh infants maintain normal blood sugar levels is not yet known. PURPOSE: Clinical trial to study how very low birth weight infants break down amino acids, fat, and sugar given by intravenous infusion, and the effect of different combinations of nutrients on the infants' ability to maintain normal blood sugar levels.
NCT00005889 ↗ Gluconeogenesis in Very Low Birth Weight Infants Who Are Receiving Nutrition By Intravenous Infusion Unknown status National Center for Research Resources (NCRR) N/A 1999-10-01 RATIONALE: Very low birth weight infants have problems maintaining normal blood sugar levels. Gluconeogenesis is the production of sugar from amino acids and fats. The best combination of amino acids, fat, and sugar to help very low birth weigh infants maintain normal blood sugar levels is not yet known. PURPOSE: Clinical trial to study how very low birth weight infants break down amino acids, fat, and sugar given by intravenous infusion, and the effect of different combinations of nutrients on the infants' ability to maintain normal blood sugar levels.
NCT00013910 ↗ NNC 90-1170 Mechanism of Action: A Double-Blind, Randomized, Single-Center, Placebo-Controlled, Crossover Study to Examine Beta-Cell Responsiveness to Graded Glucose Infusion in Subjects With Type 2 Diabetes Completed National Center for Research Resources (NCRR) Phase 1 1969-12-31 The purpose of this research study is to investigate the mechanism of action of a new investigational medication (drug), NNC 90-1170, which is being developed for the treatment of type 2 diabetes (adult onset type of diabetes. NNC 90-1170 is a modified form of a hormone, Glucagon-Like Peptide 1 (or GLP-1), which is important for controlling insulin levels. Insulin, another hormone, is also important for controlling blood glucose levels, which are higher than normal in people who have type 2 diabetes. This study will measure the effect of NNC 90-1170, active investigational drug, to cause insulin to be released from the pancreas in response to increasing blood glucose concentrations. These results will be compared to that of a group of healthy volunteers of similar age and body weight who do not have diabetes. Also, various other hormones and substances that are known to control blood sugar will be measured in blood samples that will be drawn. One dose of NNC 90-1170 will be given to subjects with type 2 diabetes only in this study, and the effects of this dose will be compared to a placebo (inactive substance that looks like the active drug). This is a crossover study, which means that subjects will be treated both with NNC 90-1170 and with placebo. The order in which subjects will receive the treatments will be determined by chance (randomly). The study will be conducted as a so-called "double-blind" study, meaning that neither subjects nor study doctors will know the order in which subjects will be given each treatment until the study is over. The study will include approximately 15 healthy volunteers and 15 volunteers with type 2 diabetes, and it will be conducted at 1 clinic (the University of Michigan Health System) in the United States.
NCT00064714 ↗ Effect of AC2993 With or Without Immunosuppression on Beta Cell Function in Patients With Type I Diabetes Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 2003-07-01 This study will determine 1) the safety of AC2993 in patients with type I diabetes; 2) the ability of AC2993 to improve beta cell function; and 3) the effects of immunosuppression on beta cell function. Type I diabetes is an autoimmune disease, in which the immune system attacks the beta cells of the pancreas. These cells produce insulin, which regulates blood sugar. AC2993 may improve the pancreas's ability to produce insulin and help control blood sugar, but it may also activate the original immune response that caused the diabetes. Thus, this study will examine the effects of AC2993 alone as well as in combination with immunosuppressive drugs. Patients between 18 and 60 years of age who have type I diabetes mellitus may be eligible for this 20-month study. They must have had diabetes for at least 5 years and require insulin treatment. Candidates will be screened with a questionnaire, followed by medical history and physical examination, blood and urine tests, a chest x-ray and skin test for tuberculosis, electrocardiogram (EKG), and arginine stimulated C-peptide test (see description below). Participants will undergo the following tests and procedures: Advanced screening phase: Participants undergo a diabetes education program, including instruction on frequent blood glucose monitoring, dietary education on counting carbohydrates, intensive insulin therapy, review of signs and symptoms of low blood sugar (hypoglycemia), and potential treatment with glucagon shots. Patients must administer insulin via an insulin pump or take at least four injections per day including glargine (Lantus) insulin. 4-month run-in phase - Arginine-stimulated C-peptide test: This test measures the body's insulin production. The patient is injected with a liquid containing arginine, a normal constituent of food that increases insulin release from beta cells into the blood stream. After the injection, seven blood samples are collected over 10 minutes. - Mixed meal stimulated C-peptide test with acetaminophen: This test assesses the response of the beta cells to an ordinary meal and the time it takes for food to pass through the stomach. The patient drinks a food supplement and takes acetaminophen (Tylenol). Blood samples are then drawn through a catheter (plastic tube placed in a vein) every 30 minutes for 4 hours to measure levels of various hormones and the concentration of acetaminophen. - Euglycemic clamp: This test measures the body's level of insulin resistance by measuring the amount of glucose necessary to compensate for an increased insulin level while maintaining a prespecified blood glucose level.
NCT00064714 ↗ Effect of AC2993 With or Without Immunosuppression on Beta Cell Function in Patients With Type I Diabetes Completed AstraZeneca Phase 2 2003-07-01 This study will determine 1) the safety of AC2993 in patients with type I diabetes; 2) the ability of AC2993 to improve beta cell function; and 3) the effects of immunosuppression on beta cell function. Type I diabetes is an autoimmune disease, in which the immune system attacks the beta cells of the pancreas. These cells produce insulin, which regulates blood sugar. AC2993 may improve the pancreas's ability to produce insulin and help control blood sugar, but it may also activate the original immune response that caused the diabetes. Thus, this study will examine the effects of AC2993 alone as well as in combination with immunosuppressive drugs. Patients between 18 and 60 years of age who have type I diabetes mellitus may be eligible for this 20-month study. They must have had diabetes for at least 5 years and require insulin treatment. Candidates will be screened with a questionnaire, followed by medical history and physical examination, blood and urine tests, a chest x-ray and skin test for tuberculosis, electrocardiogram (EKG), and arginine stimulated C-peptide test (see description below). Participants will undergo the following tests and procedures: Advanced screening phase: Participants undergo a diabetes education program, including instruction on frequent blood glucose monitoring, dietary education on counting carbohydrates, intensive insulin therapy, review of signs and symptoms of low blood sugar (hypoglycemia), and potential treatment with glucagon shots. Patients must administer insulin via an insulin pump or take at least four injections per day including glargine (Lantus) insulin. 4-month run-in phase - Arginine-stimulated C-peptide test: This test measures the body's insulin production. The patient is injected with a liquid containing arginine, a normal constituent of food that increases insulin release from beta cells into the blood stream. After the injection, seven blood samples are collected over 10 minutes. - Mixed meal stimulated C-peptide test with acetaminophen: This test assesses the response of the beta cells to an ordinary meal and the time it takes for food to pass through the stomach. The patient drinks a food supplement and takes acetaminophen (Tylenol). Blood samples are then drawn through a catheter (plastic tube placed in a vein) every 30 minutes for 4 hours to measure levels of various hormones and the concentration of acetaminophen. - Euglycemic clamp: This test measures the body's level of insulin resistance by measuring the amount of glucose necessary to compensate for an increased insulin level while maintaining a prespecified blood glucose level.
NCT00081458 ↗ Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Completed Shire Phase 3 2004-05-25 The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of teduglutide compared with placebo in subjects with parenteral nutrition (PN)-dependent short bowel syndrome (SBS).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Glucagon

Condition Name

Condition Name for Glucagon
Intervention Trials
Type 2 Diabetes 93
Type 2 Diabetes Mellitus 74
Obesity 67
Diabetes Mellitus, Type 2 64
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Condition MeSH

Condition MeSH for Glucagon
Intervention Trials
Diabetes Mellitus 356
Diabetes Mellitus, Type 2 257
Diabetes Mellitus, Type 1 137
Hypoglycemia 79
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Clinical Trial Locations for Glucagon

Trials by Country

Trials by Country for Glucagon
Location Trials
United States 702
Denmark 100
China 75
Canada 65
Germany 48
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Trials by US State

Trials by US State for Glucagon
Location Trials
Texas 64
California 52
New York 40
Pennsylvania 33
Minnesota 31
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Clinical Trial Progress for Glucagon

Clinical Trial Phase

Clinical Trial Phase for Glucagon
Clinical Trial Phase Trials
Phase 4 207
Phase 3 104
Phase 2/Phase 3 27
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Clinical Trial Status

Clinical Trial Status for Glucagon
Clinical Trial Phase Trials
Completed 468
Recruiting 106
Unknown status 82
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Clinical Trial Sponsors for Glucagon

Sponsor Name

Sponsor Name for Glucagon
Sponsor Trials
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 42
Novo Nordisk A/S 38
Eli Lilly and Company 33
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Sponsor Type

Sponsor Type for Glucagon
Sponsor Trials
Other 987
Industry 334
NIH 77
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Clinical Trials, Market Analysis, and Projections for Glucagon and GLP-1 Receptor Agonists

Introduction to Glucagon and GLP-1 Receptor Agonists

Glucagon and glucagon-like peptide-1 (GLP-1) receptor agonists are crucial in the management of diabetes and obesity. Here, we will delve into the latest clinical trials, market analysis, and future projections for these medications.

Clinical Trials Update on GLP-1 Receptor Agonists

Danuglipron: A Promising Oral GLP-1-RA Candidate

Pfizer is advancing its oral GLP-1 receptor agonist, danuglipron (PF-06882961), in late-stage clinical development for the treatment of adults with obesity and Type 2 diabetes mellitus (T2DM). Here are some key points from the ongoing trials:

  • Phase 2 Results: Danuglipron has shown dose-dependent reductions in HbA1c, fasting plasma glucose, and body weight in patients with T2DM. For example, a Phase 2 study demonstrated reductions of up to -1.16% in HbA1c, -33.24 mg/dL in fasting plasma glucose, and -4.17 kg in body weight over 16 weeks[1][4].
  • Ongoing Phase 2b Study: The study in non-diabetic obesity participants is currently ongoing, with doses ranging from 40 mg to 200 mg for up to 32 weeks. This study is expected to complete by the end of the year[1].
  • Safety Profile: The safety profile of danuglipron, including transaminase changes, appears to be similar to the peptidic GLP-1R agonist class, with no significant liver-related adverse events reported[1].

Discontinuation of Lotiglipron

Pfizer has decided to discontinue the clinical development of another GLP-1-RA candidate, lotiglipron (PF-07081532), due to pharmacokinetic data and laboratory measurements showing elevated transaminases in Phase 1 studies[1].

Market Analysis for Glucagon

Current Market Size and Growth

The global glucagon market is expected to grow significantly due to the increasing prevalence of diabetes.

  • Market Size: The glucagon market was valued at around USD 621.3 million in 2023 and is projected to reach approximately USD 1102.2 million by 2033, growing at a CAGR of 5.9% during the forecast period from 2024 to 2033[2][5].
  • Regional Dominance: North America dominates the market with a 34.5% market share in 2023, driven by a robust healthcare infrastructure[2].

Product Segmentation

The glucagon market is segmented based on product type and application:

  • Injectable Glucagon: This segment leads with a 43.9% market share in 2023, favored for emergency hypoglycemia treatment due to its swift action[2].
  • Therapeutic Use: The therapeutic use segment holds over 57.3% market share, driven by the widespread use in severe hypoglycemia emergencies[2].
  • Distribution Channels: Hospital pharmacies are expected to account for a significant portion of the revenue, estimated at USD 334.3 million by the end of 2032[5].

Future Projections and Emerging Trends

Emerging GLP-1-Based Drug Candidates

Several next-generation GLP-1-based drug candidates are in Phase 3 trials, promising significant market potential:

  • Cagrisema: A combination of a GLP-1 receptor agonist (semaglutide) and an amylin receptor agonist (Cagrilintide), Cagrisema is expected to reach risk-adjusted revenues of nearly $38 billion by 2035, surpassing other approved GLP-1 drugs like Ozempic and Wegovy[3].

Advancements in Delivery Methods

  • Nasal Sprays and Oral Formulations: Innovations in delivery methods, such as nasal sprays and oral formulations like danuglipron, are expected to enhance patient compliance and expand market opportunities[2][5].

Strategic Alliances and R&D Investments

  • Innovation Drive: Strategic alliances and significant R&D investments are driving innovation in glucagon formulations and applications, further propelling market growth[2].

Key Takeaways

  • Clinical Trials: Danuglipron is a promising oral GLP-1-RA candidate showing robust efficacy and safety in clinical trials for T2DM and obesity.
  • Market Growth: The global glucagon market is expected to grow at a CAGR of 5.9% from 2024 to 2033, driven by increasing diabetes prevalence.
  • Emerging Trends: Next-generation GLP-1-based drug candidates and advancements in delivery methods are set to transform the market.
  • Regional Focus: North America and other regions with robust healthcare infrastructure are expected to dominate the market.

FAQs

What is the current status of Pfizer's GLP-1-RA clinical development program?

Pfizer is continuing to advance the clinical program for danuglipron, an oral GLP-1 receptor agonist, for the treatment of adults with obesity and Type 2 diabetes mellitus, while discontinuing the development of lotiglipron due to adverse pharmacokinetic data[1].

How is the glucagon market expected to grow in the coming years?

The global glucagon market is projected to grow from USD 621.3 million in 2023 to approximately USD 1102.2 million by 2033, at a CAGR of 5.9% during the forecast period[2][5].

What are the key drivers of the glucagon market?

The key drivers include the increasing prevalence of diabetes, advancements in delivery methods, and strategic alliances and R&D investments in glucagon formulations and applications[2][5].

Which regions are expected to dominate the glucagon market?

North America, with its robust healthcare infrastructure, is expected to dominate the market, followed by regions like Canada, Germany, the UK, and Japan[2][5].

What are the emerging trends in GLP-1-based drug candidates?

Emerging trends include the development of next-generation GLP-1-based drug candidates like Cagrisema, which combines a GLP-1 receptor agonist with an amylin receptor agonist, and advancements in oral and nasal spray formulations[3].

Sources

  1. Pfizer Inc. - Pfizer Provides Update on GLP-1-RA Clinical Development Program for Adults with Obesity and Type 2 Diabetes Mellitus[1].
  2. Market.us - Glucagon Market Size, Share, Growth | CAGR Of 5.9%[2].
  3. Visible Alpha - Visible Alpha GLP-1 Drug Monitor: The Emerging Pipeline[3].
  4. JAMA Network Open - Efficacy and Safety of Oral Small Molecule Glucagon-Like Peptide 1 Receptor Agonist Danuglipron in Adults with Type 2 Diabetes[4].
  5. Global Market Insights - Glucagon Market Size & Share | Trends Report, 2024 – 2032[5].

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