Clinical Trials

Pramlintide Acetate has been evaluated in numerous clinical trials investigating its therapeutic efficacy across various metabolic and non-metabolic indications. Clinical investigations span Early Phase 1 through Phase 4 studies, sponsored by academic medical centers and industry leaders such as AstraZeneca, the Joslin Diabetes Center, and the Danish Headache Center. Research primarily focuses on glycemic control and weight management in patients with type 1 diabetes mellitus, type 2 diabetes mellitus, and obesity, while exploratory trials such as NCT03598075 and NCT04252612 have investigated its roles in migraine provocation and cutaneous squamous cell carcinoma. Recruitment statuses across these clinical evaluations range from completed and active to terminated or withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07679516 NOT_YET_RECRUITING
Healthy Adult Participants; Bone Physiology; Bone Blood Flow Regulation; Peptide Hormones
University of Copenhagen
 2026-07-19
NCT03560960 ACTIVE_NOT_RECRUITING
Alzheimer Disease; Mild Cognitive Impairment
Boston University
 2020-02-04 EARLY_PHASE1
NCT07506369 RECRUITING
Obesity & Overweight
University Hospital, Gentofte, Copenhagen
 2026-04
NCT06619015 WITHDRAWN
Obesity; Appetite Regulation; PreDiabetes
Esbjerg Hospital - University Hospital of Southern Denmark
 2025-04-01 PHASE2; PHASE3
NCT06046417 UNKNOWN
type1diabetes; Diabetes Mellitus, Type 1
McGill University Health Centre/Research Institute of the McGill University Health Centre
 2023-11-30 PHASE2; PHASE3
NCT06422325 COMPLETED
Type 1 Diabetes
Oregon Health and Science University
 2024-07-12
NCT06186063 UNKNOWN
Bone Diseases, Metabolic; Type 1 Diabetes
Filip Krag Knop
 2024-02-12
NCT00691158 UNKNOWN
Obesity
Oregon Health and Science University
 2006-01
NCT04243629 UNKNOWN
Diabetes Mellitus, Type 1; Type 1 Diabetes; Postprandial Hyperglycemia
McGill University
 2021-11-12
NCT04252612 WITHDRAWN
Cutaneous Squamous Cell Carcinoma
H. Lee Moffitt Cancer Center and Research Institute
 2020-01-30 EARLY_PHASE1
NCT05199714 COMPLETED
Type 1 Diabetes
McGill University Health Centre/Research Institute of the McGill University Health Centre
 2022-02-21
NCT04163874 COMPLETED
Type 1 Diabetes; Type 1 Diabetes Mellitus; Hyperglycemia, Postprandial
McGill University
 2020-02-14
NCT03800875 COMPLETED
Diabetes Mellitus, Type 1
McGill University
 2019-02-08 PHASE2
NCT04074317 COMPLETED
Diabetes Mellitus, Type 1; Insulin-dependent Diabetes Mellitus
Xeris Pharmaceuticals
 2019-08-22 PHASE2
NCT03598075 COMPLETED
Migraine Without Aura
Danish Headache Center
 2018-07-01
NCT03993366 COMPLETED
Type 1 Diabetes Mellitus
McGill University
 2019-03-01
NCT03547427 TERMINATED
Type 1 Diabetes Mellitus
University of Virginia
 2018-05-20
NCT03916640 COMPLETED
Type 1 Diabetes Mellitus
Adocia
 2019-01-04 PHASE1
NCT03512236 COMPLETED
Type 1 Diabetes Mellitus
Adocia
 2018-04-25 PHASE1
NCT02814123 COMPLETED
Diabetes Mellitus, Type 1
McGill University
 2017-01-13 PHASE2
NCT02500979 COMPLETED
Type 1 Diabetes Mellitus
AstraZeneca
 2015-08-17 PHASE1
NCT01269047 COMPLETED
Type 1 Diabetes
Albert Einstein College of Medicine
 2009-08 PHASE4
NCT01841359 COMPLETED
Hypoglycemia; Evidence of Previous Gastric Surgery
Joslin Diabetes Center
 2010-02-02 PHASE4
NCT01839370 COMPLETED
Diabetes Mellitus, Type 1
University of Virginia
 2013-07
NCT01708044 COMPLETED
Type 1 Diabetes
AstraZeneca
 2012-11 PHASE1
NCT01269008 COMPLETED
Type 1 Diabetes
Albert Einstein College of Medicine
 2010-12 PHASE1
NCT01434862 TERMINATED
Type 1 Diabetes Mellitus
University of Virginia
 2011-02
NCT01137695 UNKNOWN
Type 2 Diabetes Mellitus
Cheryl Rosenfeld, DO
 2010-05 PHASE3
NCT01235741 TERMINATED
Obesity
AstraZeneca
 2011-01 PHASE2
NCT01165944 WITHDRAWN
Diabetes Mellitus
University of Colorado, Denver
 2009-08 PHASE1; PHASE2
NCT00690235 COMPLETED
Schizophrenia; Schizoaffective Disorder; Diabetes; Weight Gain
University of Texas Southwestern Medical Center
 2007-11 PHASE4
NCT00950677 COMPLETED
Type 2 Diabetes
Baylor College of Medicine
 2009-07 PHASE4
NCT00732147 WITHDRAWN
Type 2 Diabetes
University of Maryland, Baltimore
 2009-04
NCT00842075 COMPLETED
Type 1 Diabetes
University of Colorado, Denver
 2006-12
NCT00819234 COMPLETED
Obesity
AstraZeneca
 2008-11 PHASE2
NCT00673387 COMPLETED
Overweight; Obesity
AstraZeneca
 2008-04 PHASE2
NCT00442767 COMPLETED
Type 1 Diabetes Mellitus
Montefiore Medical Center
 2007-02 PHASE4
NCT00505882 WITHDRAWN
Type 1 Diabetes
University of Texas Southwestern Medical Center
 2007-07 PHASE4
NCT00460304 COMPLETED
Type 1 Diabetes
Diabetes Care Center
 2007-09
NCT00467649 COMPLETED
Type 2 Diabetes Mellitus
AstraZeneca
 2007-05 PHASE4
NCT00502138 COMPLETED
IDDM
University Diabetes & Endocrine Consultants
 2007-07 PHASE4
NCT00291772 COMPLETED
Type 1 Diabetes
Baylor College of Medicine
 2006-01 PHASE4
NCT00392925 COMPLETED
Overweight; Obesity
AstraZeneca
 2006-10 PHASE2
NCT00313183 COMPLETED
Type 1 Diabetes Mellitus
AstraZeneca
 2006-04 PHASE2
NCT00402077 COMPLETED
Overweight; Obesity
AstraZeneca
 2006-11 PHASE2
NCT00189514 COMPLETED
Obesity
AstraZeneca
 2005-09 PHASE2
NCT00489645 COMPLETED
Type 1 Diabetes
Ludwig-Maximilians - University of Munich
 2005-01
NCT00240253 COMPLETED
Type 2 Diabetes Mellitus
AstraZeneca
 2005-10 PHASE4
NCT00112021 COMPLETED
Obesity
AstraZeneca
 2005-05 PHASE2
NCT00107107 COMPLETED
Diabetes Mellitus, Type 1
AstraZeneca
 2002-11 PHASE3
NCT00108004 COMPLETED
Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus
AstraZeneca
 2003-04 PHASE3
NCT00444561 COMPLETED
Overweight; Obesity
AstraZeneca
 2004-08 PHASE2
NCT00042601 COMPLETED
Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
AstraZeneca
 2002-07 PHASE2
NCT00042458 COMPLETED
Diabetes Mellitus, Type 1
AstraZeneca
 2002-04 PHASE3
NCT00042471 COMPLETED
Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
AstraZeneca
 2002-06 PHASE2
NCT00044707 COMPLETED
Diabetes Mellitus, Non-Insulin-Dependent
AstraZeneca
 2002-08 PHASE2
NCT00206258 COMPLETED
Type 1 Diabetes
Baylor College of Medicine
 2002-07 PHASE3
NCT00206297 COMPLETED
Type 1 Diabetes
Baylor College of Medicine
 2003-10 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-07-09)

Check the Pramlintide Acetate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pramlintide Acetate is a synthetic peptide analog of human amylin that selectively binds to and activates high-affinity amylin receptors in the central nervous system. This receptor activation slows gastric emptying, suppresses postprandial glucagon secretion, and enhances satiety, which collectively reduces postprandial blood glucose fluctuations in clinical conditions such as type 1 and type 2 diabetes mellitus.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.