Cotadutide (MEDI0382): Dosing Protocols
Dosing guidelines, reconstitution, and administration information
๐TL;DR
- โข1 dosing protocols documented
- โขReconstitution instructions included
- โขStorage: Clinical trial formulations were stored refrigerated at 2-8 degrees C. Specific stability and storage data were not publicly disclosed as the product never reached commercial development.
Protocol Quick-Reference
Type 2 diabetes and weight management
Dosing
Amount
100-300 mcg
Frequency
Once daily
Duration
54 weeks (Phase 2b trial)
Administration
Route
SCSchedule
Once daily
Timing
Dose escalation from starting dose to target maintenance dose to mitigate GI adverse events. Consistent with standard GLP-1 agonist titration.
Cycle
Duration
54 weeks (Phase 2b)
Repeatable
Single cycle
โ๏ธ Suggested Bloodwork (4 tests)
HbA1c
When: Baseline and every 14 weeks
Why: Monitor glycemic control
Liver function tests (ALT, AST)
When: Baseline and every 14 weeks
Why: Monitor hepatic biomarkers relevant to NASH
Fasting glucose and insulin
When: Baseline and 14 weeks
Why: Assess metabolic response
Lipid panel
When: Baseline and 14 weeks
Why: Monitor metabolic parameters
๐ก Key Considerations
- โDiscontinued: cotadutide development was halted in April 2023 and is not available for clinical use
- โGI adverse events (nausea 35%, vomiting 17%) are the most common side effects
- โDose escalation is essential to improve tolerability
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| Purpose | Dose | Frequency | Duration | Notes |
|---|---|---|---|---|
| Once daily | Investigational dosing from clinical trials only. Cotadutide development was discontinued in April 2023. Not available for clinical use or purchase. |
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๐Reconstitution Instructions
In clinical trials, cotadutide was provided as a ready-to-use solution for subcutaneous injection. No reconstitution was required. Specific formulation details were proprietary to AstraZeneca.
Recommended Injection Sites
- โAbdomen
- โThigh
- โUpper arm
๐งStorage Requirements
Clinical trial formulations were stored refrigerated at 2-8 degrees C. Specific stability and storage data were not publicly disclosed as the product never reached commercial development.
Community Dosing Protocols
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Before You Begin
Review safety warnings and contraindications before starting any protocol.
Investigational Dosing Information#
Cotadutide (MEDI0382) was an investigational compound that was never approved by any regulatory authority. The dosing information below is from clinical trials only and is provided for educational purposes. Cotadutide development was discontinued by AstraZeneca in April 2023.
Phase 2b Trial Dosing#
In the pivotal phase 2b trial (Nahra et al., 2021; n=834), cotadutide was studied at three dose levels:
- 100 mcg once daily: Lowest dose studied, with dose escalation from a starting dose
- 200 mcg once daily: Mid-range dose, producing weight loss similar to liraglutide 1.8 mg
- 300 mcg once daily: Highest dose studied, producing weight loss exceeding liraglutide 1.8 mg and the most significant hepatic improvements
All doses were administered as once-daily subcutaneous injections. Dose escalation protocols were employed to mitigate gastrointestinal side effects, consistent with standard GLP-1 agonist dose titration strategies.
Dose-Response Relationship#
The phase 2b data showed a clear dose-response across the three dose levels:
| Parameter | 100 mcg | 200 mcg | 300 mcg | Liraglutide 1.8 mg |
|---|---|---|---|---|
| HbA1c reduction | Significant vs placebo | Significant vs placebo | Significant vs placebo | Active comparator |
| Weight loss | Modest | Similar to liraglutide | Greater than liraglutide | Comparator |
| Hepatic biomarkers | Limited effect | Moderate effect | Significant improvement | No significant effect |
The 300 mcg dose demonstrated the most favorable risk-benefit profile, with meaningful improvements in hepatic parameters (ALT, AST, fibrosis biomarkers) that were not observed with the GLP-1-only comparator liraglutide.
Phase 2a Dosing#
The earlier phase 2a study (Ambery et al., 2018) used ascending doses up to 300 mcg daily in a smaller patient population, establishing the safety and preliminary efficacy that supported the phase 2b program.
Limitations#
As an investigational compound that never reached phase 3 or regulatory approval, optimal dosing was never definitively established. The once-daily dosing frequency was considered a competitive disadvantage versus weekly GLP-1 agonists, contributing to AstraZeneca's strategic decision to discontinue cotadutide in favor of a weekly successor.
Dosing Context#
Cotadutide (MEDI0382) belongs to the Metabolic category of research peptides. Dosing protocols for Cotadutide (MEDI0382) are derived from available clinical trial data. These protocols are provided for research reference only and do not constitute medical advice. Actual dosing decisions should be made by qualified healthcare providers based on individual patient factors.
Research Protocols#
The following dosing protocols have been documented in clinical research for Cotadutide (MEDI0382):
undefined#
Dose: undefined
Frequency: Once daily
Duration: undefined
Investigational dosing from clinical trials only. Cotadutide development was discontinued in April 2023. Not available for clinical use or purchase.
Reconstitution and Preparation#
In clinical trials, cotadutide was provided as a ready-to-use solution for subcutaneous injection. No reconstitution was required. Specific formulation details were proprietary to AstraZeneca.
Injection Sites#
Recommended injection sites for Cotadutide (MEDI0382) include:
- Abdomen
- Thigh
- Upper arm
Site rotation is recommended to minimize local tissue reactions and ensure consistent absorption.
Storage Requirements#
Clinical trial formulations were stored refrigerated at 2-8 degrees C. Specific stability and storage data were not publicly disclosed as the product never reached commercial development.
Related Reading#
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Medical Disclaimer
This website is for educational and informational purposes only. The information provided is not intended to diagnose, treat, cure, or prevent any disease. Always consult with a qualified healthcare professional before using any peptide or supplement.