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▎Editor of WuXi AppTec Content Team On May 20, 2021, Eli Lilly and Company announced its glucose-dependent insulin-promoting polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors The dual agonist tirzepatide reached the primary endpoint and all key secondary endpoints in a clinical trial called SURPASS-4.
Compared with the active control group, in adult patients with type 2 diabetes with increased cardiovascular (CV) risk, the three different doses of tirzepatide significantly reduced the patients' glycosylated hemoglobin (A1C) and body weight.
In the patient group receiving the highest dose (15 mg), after 52 weeks of treatment, tirzepatide succeeded in achieving normal A1C levels in 43% of patients, with an average weight loss of 11.
7 kg.
So far, tirzepatide has reached the primary endpoint in all 5 global phase 3 clinical trials.
Tirzepatide is a dual-receptor agonist of GIP and GLP-1 under investigation once a week.
It integrates the effects of these two incretins into a new molecule and is a new method for the treatment of type 2 diabetes.
GIP is a hormone that may complement the effects of GLP-1 receptor agonists.
Pre-clinical models have proven that GIP can reduce food intake and increase energy expenditure, thereby causing patients to lose weight.
Moreover, when GIP is used in combination with GLP-1 receptor agonists, it may have a greater impact on the patient's blood sugar level and weight.
Tirzepatide is currently in phase 3 clinical development for blood glucose management and chronic weight management in adult patients with type 2 diabetes.
It is also used as a potential treatment for non-alcoholic steatohepatitis (NASH) and heart failure with preserved ejection fraction (HFpEF).
The SURPASS-4 trial aims to evaluate the effectiveness and safety of three different doses of tirzepatide (5 mg, 10 mg and 15 mg) in the treatment of 2002 type 2 diabetes patients.
The average diabetes history of these patients was 11.
8 years, the baseline A1C was 8.
52%, the baseline weight was 90.
3 kg, and more than 85% of the subjects had a history of cardiovascular events.
SURPASS-4 reached the primary and critical secondary endpoints.
The test results showed that compared with the control group using insulin glargine, the three doses of tirzepatide (5 mg, 10 mg, and 15 mg) all caused a greater degree of A1C and weight loss in patients.
In the group of patients treated with the highest dose of 15 mg of tirzepatide, the average A1C level of the patients was reduced by 2.
41%, and the average body weight was reduced by 11.
7 kg.
Moreover, 91% of patients have A1C levels below 7%, which is the standard recommended by the American Diabetes Association for diabetic patients.
At the same time, 43% of patients achieved A1C less than 5.
7%, which is the standard for healthy people without diabetes.
▲At 52 weeks, the efficacy data of tirzepatide in the SURPASS-4 clinical trial (data source: reference [1]) Tirzepatide's overall safety profile is consistent with GLP-1 receptor agonist drugs.
Gastrointestinal side effects are the most frequently reported adverse events.
They are usually mild to moderate in severity.
They usually occur during the escalation of therapeutic doses and then decrease over time.
In the Tirzepatide treatment group, the frequency of adverse events such as nausea (11.
9%, 15.
9%, 22.
2%), diarrhea (12.
2%, 19.
5%, 20.
4%) and vomiting (4.
9%, 8.
2%, 8.
3%) was higher than that of the control group .
In addition, the treatment discontinuation rates due to adverse events were 8.
2%, 7.
3%, and 8.
9%, respectively, compared with 2.
9% in the control group. "These strong results reinforce our belief that tirzepatide may become an exciting new treatment for type 2 diabetes.
" said Michael Mason, President of Eli Lilly Diabetes.
"We look forward to bringing Tirzepatide to patients with type 2 diabetes.
Come an important new therapy, and detailed results will be submitted to regulatory agencies later this year.
"Reference: [1] Lilly's tirzepatide achieves all primary and key secondary study outcomes against insulin glargine in adults with type 2 diabetes and increased cardiovascular risk in SURPASS-4 trial.
May 20, 2021, from https://investor.
lilly.
com/news-releases/news-release-details/lillys-tirzepatide-achieves-all-primary-and-key-secondary -study Note: This article aims to introduce the progress of medical and health research, not to recommend treatment options.
If you need guidance on the treatment plan, please go to a regular hospital for treatment.
Compared with the active control group, in adult patients with type 2 diabetes with increased cardiovascular (CV) risk, the three different doses of tirzepatide significantly reduced the patients' glycosylated hemoglobin (A1C) and body weight.
In the patient group receiving the highest dose (15 mg), after 52 weeks of treatment, tirzepatide succeeded in achieving normal A1C levels in 43% of patients, with an average weight loss of 11.
7 kg.
So far, tirzepatide has reached the primary endpoint in all 5 global phase 3 clinical trials.
Tirzepatide is a dual-receptor agonist of GIP and GLP-1 under investigation once a week.
It integrates the effects of these two incretins into a new molecule and is a new method for the treatment of type 2 diabetes.
GIP is a hormone that may complement the effects of GLP-1 receptor agonists.
Pre-clinical models have proven that GIP can reduce food intake and increase energy expenditure, thereby causing patients to lose weight.
Moreover, when GIP is used in combination with GLP-1 receptor agonists, it may have a greater impact on the patient's blood sugar level and weight.
Tirzepatide is currently in phase 3 clinical development for blood glucose management and chronic weight management in adult patients with type 2 diabetes.
It is also used as a potential treatment for non-alcoholic steatohepatitis (NASH) and heart failure with preserved ejection fraction (HFpEF).
The SURPASS-4 trial aims to evaluate the effectiveness and safety of three different doses of tirzepatide (5 mg, 10 mg and 15 mg) in the treatment of 2002 type 2 diabetes patients.
The average diabetes history of these patients was 11.
8 years, the baseline A1C was 8.
52%, the baseline weight was 90.
3 kg, and more than 85% of the subjects had a history of cardiovascular events.
SURPASS-4 reached the primary and critical secondary endpoints.
The test results showed that compared with the control group using insulin glargine, the three doses of tirzepatide (5 mg, 10 mg, and 15 mg) all caused a greater degree of A1C and weight loss in patients.
In the group of patients treated with the highest dose of 15 mg of tirzepatide, the average A1C level of the patients was reduced by 2.
41%, and the average body weight was reduced by 11.
7 kg.
Moreover, 91% of patients have A1C levels below 7%, which is the standard recommended by the American Diabetes Association for diabetic patients.
At the same time, 43% of patients achieved A1C less than 5.
7%, which is the standard for healthy people without diabetes.
▲At 52 weeks, the efficacy data of tirzepatide in the SURPASS-4 clinical trial (data source: reference [1]) Tirzepatide's overall safety profile is consistent with GLP-1 receptor agonist drugs.
Gastrointestinal side effects are the most frequently reported adverse events.
They are usually mild to moderate in severity.
They usually occur during the escalation of therapeutic doses and then decrease over time.
In the Tirzepatide treatment group, the frequency of adverse events such as nausea (11.
9%, 15.
9%, 22.
2%), diarrhea (12.
2%, 19.
5%, 20.
4%) and vomiting (4.
9%, 8.
2%, 8.
3%) was higher than that of the control group .
In addition, the treatment discontinuation rates due to adverse events were 8.
2%, 7.
3%, and 8.
9%, respectively, compared with 2.
9% in the control group. "These strong results reinforce our belief that tirzepatide may become an exciting new treatment for type 2 diabetes.
" said Michael Mason, President of Eli Lilly Diabetes.
"We look forward to bringing Tirzepatide to patients with type 2 diabetes.
Come an important new therapy, and detailed results will be submitted to regulatory agencies later this year.
"Reference: [1] Lilly's tirzepatide achieves all primary and key secondary study outcomes against insulin glargine in adults with type 2 diabetes and increased cardiovascular risk in SURPASS-4 trial.
May 20, 2021, from https://investor.
lilly.
com/news-releases/news-release-details/lillys-tirzepatide-achieves-all-primary-and-key-secondary -study Note: This article aims to introduce the progress of medical and health research, not to recommend treatment options.
If you need guidance on the treatment plan, please go to a regular hospital for treatment.
