Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SHP681 · 1 trial · 1 indication
Adverse event (AE) was any unfavorable and unintended sign, symptom, or disease temporally associated with study or use of investigational drug product (IP), whether or not the AE was considered related to IP. TEAEs: AEs occurring or worsening at or after first dose of IP or ongoing at time of enrollment. SAE :untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. Severity: Mild: event that does not generally interfere with usual activities of daily living; Moderate: event that interferes with usual activities of daily living, causing discomfort, permanent risk of harm; Severe: AE that interrupts usual activities of daily living, significantly affects clinical status, or may require intensive therapeutic intervention.
AE was any unfavorable and unintended sign, symptom, or disease temporally associated with study or use of investigational drug product (IP), whether or not the AE was considered related to IP. TEAEs: AEs occurring or worsening at or after first dose of IP or ongoing at time of enrollment. SAE :untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. Severity: Mild: event that does not generally interfere with usual activities of daily living; Moderate: event that interferes with usual activities of daily living, causing discomfort, permanent risk of harm; Severe: AE that interrupts usual activities of daily living, significantly affects clinical status, or may require intensive therapeutic intervention.
Antibody testing was conducted using an electro chemiluminescent signal method. Number of participants with ADA to SHP681 in SAD at Day 29 were reported.
Antibody testing was conducted using an electro chemiluminescent signal method. Number of participants with ADA to SHP681 in MAD at Day 36 were reported.
Antibody testing was conducted using an electro chemiluminescent signal method. Number of participants with ADA to SHP681 in MAD at Day 57 were reported.
| Arm | Type | Description |
|---|---|---|
| Single Ascending Dose (SAD): 0.2 mg/kg | EXPERIMENTAL | Participants will receive single subcutaneous (SC) injection of 0.2 mg/kg SHP681 in the abdomen. |
| Single Ascending Dose (SAD): 0.5 mg/kg | EXPERIMENTAL | Participants will receive single SC injection of 0.5 mg/kg SHP681 in the abdomen. |
| Single Ascending Dose (SAD): 1 mg/kg | EXPERIMENTAL | Participants will receive single SC injection of 1 mg/kg SHP681 in the abdomen. |
| Single Ascending Dose (SAD): 2 mg/kg | EXPERIMENTAL | Participants will receive single SC injection of 2 mg/kg SHP681 in the abdomen. |
| Single Ascending Dose (SAD): 4 mg/kg | EXPERIMENTAL | Participants will receive single SC injection of 4 mg/kg SHP681 in the abdomen. |
| Single Ascending Dose (SAD): Placebo | PLACEBO_COMPARATOR | Participants will receive single SC injection of placebo matched to SHP681 in the abdomen. |
| Multiple Ascending Dose (MAD): 0.2 mg/kg | EXPERIMENTAL | Participants will receive SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen. |
| Multiple Ascending Dose (MAD): 0.5 mg/kg | EXPERIMENTAL | Participants will receive SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen. |
| Multiple Ascending Dose (MAD): 1 mg/kg | EXPERIMENTAL | Participants will receive SC injection of 1 mg/kg SHP681 once weekly for 5 weeks in the abdomen. |
| Multiple Ascending Dose (MAD): 2 mg/kg | EXPERIMENTAL | Participants will receive SC injection of 2 mg/kg SHP681 once weekly for 5 weeks in the abdomen. |
| Multiple Ascending Dose (MAD): 4 mg/kg | EXPERIMENTAL | Participants will receive SC injection of 4 mg/kg SHP681 once weekly for 5 weeks in the abdomen. |
| Multiple Ascending Dose (MAD): Placebo | PLACEBO_COMPARATOR | Participants will receive SC injection of placebo matched to SHP681 once weekly for 5 weeks in the abdomen. |
| Name | Type | Description |
|---|---|---|
| SHP681 | DRUG | Participants will receive SC injection of SHP681 in the abdomen. |
| Placebo | OTHER | Participants will receive SC injection of placebo matched to SHP681 in the abdomen. |
Inclusion Criteria: * Ability to voluntarily provide written, signed, and dated informed consent to participate in the study. * An understanding, ability, and willingness to fully comply with study procedures and restrictions. * Age 18-50 inclusive at the time of consent. The date of signature of t...
SHP681 is an investigational small molecule being developed by Takeda Pharmaceutical Company Limited. It is a glucagon-like peptide-2 (GLP-2) analog-Fc fusion protein. As of the latest available data, it is in Phase 1 clinical development, having completed a study in healthy adult participants.
SHP681 is being studied for use in healthy volunteers. The completed Phase 1 trial assessed its safety, tolerability, and pharmacokinetics after ascending subcutaneous doses, both single and multiple, in healthy adult participants. Its intended therapeutic use has not been established.
SHP681 is a glucagon-like peptide-2 (GLP-2) analog-Fc fusion protein. GLP-2 is a peptide that plays a role in intestinal growth and function. The Fc fusion portion is designed to extend the half-life of the molecule. The specific mechanism of action is being evaluated in clinical trials.
SHP681 is being developed by Takeda Pharmaceutical Company Limited, a biopharmaceutical company. Takeda is listed on the stock exchange under the ticker symbol TAK. The company is conducting clinical research to evaluate the safety and pharmacokinetics of SHP681.
SHP681 is in Phase 1 clinical development. A Phase 1 study, NCT03859323, has been completed. This study was a randomized, double-blind, placebo-controlled trial that enrolled 104 healthy adult participants in the United States. The trial evaluated ascending subcutaneous doses of SHP681.
SHP681 has one completed clinical trial, NCT03859323. This was a Phase 1 study titled 'A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ascending, Subcutaneous, Single and Multiple Doses of SHP681 (Glucagon-like Peptide-2 [GLP-2] Analog-Fc Fusion) in Healthy Adult Participants.' The study enrolled 104 participants and was conducted in the United States.