Endocrine & Metabolic clinical trial failures

Phase III Secondary Hyperparathyroidism-Chronic Kidney Disease trial by Sanofi. Stop reason: OPERATIONAL.

The study was conducted to fulfill a post-marketing commitment (PMC).FDA acknowledged the fulfillment of this PMC.

Unknown Diabetes Type 2 trial by Richmond Pharmacology Limited. Stop reason: EFFICACY/FUTILITY.

The study is being terminated early on the grounds of futility, as continuation of the study is no longer considered scientifically or operationally justified.

Phase IV Congenital Hypothyroidism trial by IBSA Institut Biochimique SA. Stop reason: OPERATIONAL.

Inability to recruit subjects

Phase IV Diabetes Mellitus, Type 2 trial by University of Illinois at Chicago. Stop reason: OPERATIONAL.

Low recruitment rate and an inability to meet power.

Phase III Chronic Kidney Disease (CKD) trial by AbbVie. Stop reason: OPERATIONAL.

Company Decision

Phase II Homozygous Familial Hypercholesterolemia trial by Arrowhead Pharmaceuticals. Stop reason: OPERATIONAL.

Business decision, unrelated to safety concerns.

Phase I Diabetes Mellitus, Type 2 trial by McMaster University. Stop reason: OTHER/UNKNOWN.

Withdrawn

Phase II Diabetes Mellitus, Type 1 trial by Tolerion, Inc.. Stop reason: SAFETY.

The DSMB concluded that there was a low probability the study would meet it is primary endpoint as designed.

Phase II Diabetes Mellitus trial by Albert Einstein College of Medicine. Stop reason: OPERATIONAL.

Protocol was terminated due to enrollment + feasibility issues. Aim 2 not conducted. Aims 1 + 3 were conducted in part. During Aim 3 the IRB requested that the study be transitioned under a new protocol (2018-9208) in order to simplify reporting.

Phase II Type 1 Diabetes Mellitus trial by Biomea Fusion Inc.. Stop reason: OPERATIONAL.

Sponsor made a business decision to terminate the study based on prioritization of portfolio.

Phase II Diabetes Mellitus, Type 1 trial by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Stop reason: OPERATIONAL.

Study terminated early due to low enrollment and lack of feasibility to meet target enrollment.

Phase IV Parathyroid Dysfunction trial by University of Alabama at Birmingham. Stop reason: OPERATIONAL.

Funding halted

Phase III Thyroid Eye Disease trial by Immunovant Sciences GmbH. Stop reason: SAFETY.

The feeder studies (i.e., IMVT-1401-3201 and 3202) for study IMVT-1401-3203 failed to achieve their pre-defined primary efficacy outcomes. Accordingly, there was a change to the benefit-risk balance. No new safety findings were observed.

Phase II Chronic Kidney Disease Stage 2 trial by Enyo Pharma. Stop reason: OPERATIONAL.

Pilot cohort (n=10) yielded useful insights but data remains exploratory due to limited sample size. Study stopped due to strategic reprioritization.

Phase I Diabetes Mellitus, Type 2 trial by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.. Stop reason: OPERATIONAL.

Study terminated for strategic business reasons.

Phase I Type 2 Diabetes Mellitus trial by AstraZeneca. Stop reason: SAFETY.

Safety issue was identified in the Phase2b D7860C00006 study, evaluating AZD6793 in moderate to very severe COPD participants. D7860C00005 study is temporary halted to amend the design to reflect changes implemented in the ongoing D7860C00006 study

Phase II Obesity trial by Esbjerg Hospital - University Hospital of Southern Denmark. Stop reason: OTHER/UNKNOWN.

suspended by the danish medical agency

Phase III Thyroid Eye Disease trial by Novartis Pharmaceuticals. Stop reason: OTHER/UNKNOWN.

Analysis of blinded patient data showed a very low probability of the study meeting the primary efficacy endpoints. No safety concerns were identified

Phase II Spinal Cord Injuries trial by Dr. B. Catharine. Craven. Stop reason: OPERATIONAL.

COVID-19 Pandemic

Phase I Dyslipidemias trial by Eli Lilly and Company. Stop reason: OTHER/UNKNOWN.

Participants were not dosed in Part B as per the protocol.

Phase II Diabetes Mellitus, Type 1 trial by University of Virginia. Stop reason: OTHER/UNKNOWN.

Institution transfer

Phase II Obesity trial by Centre for Addiction and Mental Health. Stop reason: OTHER/UNKNOWN.

Poor tolerability of medication and no preliminary efficacy

Phase I Thyroid Eye Disease trial by Peter Timoney. Stop reason: OPERATIONAL.

Low enrollment status

Early Phase I Multiple Sclerosis trial by University of Chicago. Stop reason: OTHER/UNKNOWN.

Study pending amendment

Phase II Thyroid trial by M.D. Anderson Cancer Center. Stop reason: OPERATIONAL.

\<75% participant accrual

Phase II Obesity trial by University of Iowa. Stop reason: OPERATIONAL.

Lack of funding

Phase II Kidney Transplant trial by Duke University. Stop reason: OPERATIONAL.

The study closed per PI decision due to completion of the biopsy substudy and slow accrual

Phase II Diabetes Mellitus, Type 2 trial by Halia Therapeutics, Inc.. Stop reason: OPERATIONAL.

Business decision to move away from this indication with this intervention, and low enrollment.

Phase II Type 2 Diabetes Mellitus (T2DM) trial by Cytoki Pharma. Stop reason: OPERATIONAL.

The study was terminated after the recruitment had been completed due to a decision to discontinue development of CK-0045

Phase IV Diabetes Mellitus, Type 2 trial by Boston University. Stop reason: OTHER/UNKNOWN.

The study was halted early because of the inability to enroll participants.

Phase I Type 1 Diabetes Mellitus trial by National Institute of Allergy and Infectious Diseases (NIAID). Stop reason: OPERATIONAL.

Prior to termination the DESIGNATE study was an on enrollment hold due to greater than anticipated lymphodepletion. The pharmaceutical partner decided not to reopen its own T1D trial and ceased development of siplizumab in autoimmunity.

Phase IV Type 2 Diabetes trial by Centre Hospitalier Universitaire Dijon. Stop reason: OTHER/UNKNOWN.

Exploratory protocol, convincing results, robust analysis

Phase IV Type 2 Diabetes trial by Centre Hospitalier Universitaire Dijon. Stop reason: OTHER/UNKNOWN.

Failure of inclusion

Phase II PreDiabetes trial by Diana Jalal. Stop reason: OPERATIONAL.

No funding

Phase I Thyroid Disease trial by OPTOSURGICAL, LLC. Stop reason: OTHER/UNKNOWN.

The NIH-funded project period has come to an end.

Early Phase I Healthy trial by University of Missouri-Columbia. Stop reason: OTHER/UNKNOWN.

Interim data and power analysis

Phase IV Obesity trial by United States Army Research Institute of Environmental Medicine. Stop reason: OPERATIONAL.

lack of funding

Phase III Diabetes Mellitus, Type 2 trial by Eurofarma Laboratorios S.A.. Stop reason: OTHER/UNKNOWN.

Strategic change in development priorities

Phase III Type 2 Diabetes Mellitus (T2DM) trial by Eurofarma Laboratorios S.A.. Stop reason: OTHER/UNKNOWN.

Strategic change in development priorities

Phase III Overweight trial by Eurofarma Laboratorios S.A.. Stop reason: OTHER/UNKNOWN.

Strategic change in development priorities

Phase II Recent Onset type1 Diabetes trial by Dompé Farmaceutici S.p.A. Stop reason: EFFICACY/FUTILITY.

The study was stopped due to futility as per protocol

Phase II Thyroid trial by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. Stop reason: OPERATIONAL.

Poor accrual

Early Phase I Obesity and Overweight trial by Helicore Biopharma, Inc.. Stop reason: OPERATIONAL.

Business decision

Phase I Obesity trial by University of North Carolina, Chapel Hill. Stop reason: OPERATIONAL.

Lack of funding

Phase IV Weight Loss trial by Loma Linda University. Stop reason: OPERATIONAL.

Difficult to recruit. an unexpected result is the easy availability of GLP 1 medication to the general public.

Early Phase I Type1 Diabetes Mellitus trial by University of Maryland, Baltimore. Stop reason: OTHER/UNKNOWN.

We were unable to obtain GLP-1

Phase IV Diabetes Mellitus, Type II trial by Brigham and Women's Hospital. Stop reason: OTHER/UNKNOWN.

No participants were enrolled in the trial.

Phase II Familial Partial Lipodystrophy trial by Regeneron Pharmaceuticals. Stop reason: OPERATIONAL.

Sponsor Decision

Phase I Diabetes Mellitus Type 1 trial by Seraxis. Stop reason: OPERATIONAL.

Study is being withdrawn for business reasons

Phase II Breast Cancer trial by UNC Lineberger Comprehensive Cancer Center. Stop reason: OTHER/UNKNOWN.

Grant ended

Phase III Type2 Diabetes trial by Kowa Research Institute, Inc.. Stop reason: EFFICACY/FUTILITY.

The study was stopped for futility based on efficacy results at the interim analysis; no unexpected safety findings were observed.

Phase II Obesity trial by Eli Lilly and Company. Stop reason: OPERATIONAL.

Study terminated for strategic business reasons

Phase I Obesity trial by Regeneron Pharmaceuticals. Stop reason: OPERATIONAL.

Sponsor Decision

Phase IV Diabetes Mellitus, Type 1 trial by Albert Einstein College of Medicine. Stop reason: OPERATIONAL.

Study suspended for a prolonged duration due to the Pandemic. Once research resumed project was streamlined due to insufficient resources. Study was sufficiently powered to conduct analysis for 2 of the arms. Remaining Aims were never initiated.

Phase IV Type 2 Diabetes Mellitus trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor decision to cancel trial due to poor recruitment/ severe recruitment delay and not related to safety concern.

Phase I Obesity-Associated Insulin Resistance trial by Italo Biaggioni. Stop reason: OTHER/UNKNOWN.

Study being replaced by crossover design

Phase II Obesity trial by Eli Lilly and Company. Stop reason: OPERATIONAL.

Study terminated for strategic business reasons

Phase I Obesity trial by University of California, San Francisco. Stop reason: OPERATIONAL.

No funding

Phase II Diabetes Mellitus, Type 1 trial by ITB-Med LLC. Stop reason: OPERATIONAL.

The study has been early terminated due to business reasons. This decision is not related to any safety, efficacy, or regulatory concerns.

Phase I Overweight trial by Pfizer. Stop reason: OTHER/UNKNOWN.

The sponsor has made the decision to discontinue development of danuglipron (PF-06882961). As such, this study was discontinued prior to PF-06882961 administration.

Phase IV Hypothyroidism trial by Bracco Diagnostics, Inc. Stop reason: OTHER/UNKNOWN.

Formal release from PMR

Phase III Chronic Kidney Disease stage3 trial by OPKO Health, Inc.. Stop reason: OPERATIONAL.

FDA changed the post-marketing requirement necessitating a new study design and protocol.

Phase III Thyroid Nodule, Toxic or With Hyperthyroidism trial by Rijnstate Hospital. Stop reason: OTHER/UNKNOWN.

Switched from RCT to observational prospective cohort due to termination of subsidy (delay due to insufficient inclusion-rate). Follow-up of RCT-arm will be completed. Patients can still be included in a observational cohort.

Phase II Schizophrenia trial by Sadat City University. Stop reason: OPERATIONAL.

Institutional and funding constrains

Phase IV Polycystic Ovary Syndrome trial by Columbia University. Stop reason: OPERATIONAL.

Poor enrollment, administrative challenges, and lack of funding

Phase I Type 2 Diabetes trial by University of Maryland, Baltimore. Stop reason: OPERATIONAL.

We concluded that it would not be possible to meet our recruitment targets within the available budget. The study was ended when the funding ended.

Phase I Papillary Thyroid Cancer trial by AHS Cancer Control Alberta. Stop reason: OPERATIONAL.

Lack of Accrual

Phase I Diabetes type1 trial by University of Alberta. Stop reason: OPERATIONAL.

Due to feasibility challenges and following mutual agreement by JDRF CCTN and the Principal Investigator for Statement of Work 4 (SOW4), the study conducted by Dr. James Shapiro has been withdrawn/terminated.

Phase I Type 1 Diabetes trial by St. Olavs Hospital. Stop reason: OTHER/UNKNOWN.

No sign of anticipated effect.

Phase II Osteoporosis, Postmenopausal trial by University of Mississippi Medical Center. Stop reason: OPERATIONAL.

Not able to recruit participants

Phase II Type 1 Diabetes trial by St. Olavs Hospital. Stop reason: OTHER/UNKNOWN.

No sign of the anticipated effect.

Phase II CKD trial by Barts & The London NHS Trust. Stop reason: OPERATIONAL.

Lack of recruitment

Phase II Pediatric Obesity trial by Janey Pratt. Stop reason: OPERATIONAL.

No available funding

Phase II Diabetes Mellitus, Type 2 trial by Meredith Hawkins. Stop reason: OPERATIONAL.

Grant funding ended. NIDDK grant renewed without an MR aim. No plans to do future studies.

Phase II Renal Insufficiency, Chronic trial by Biogen. Stop reason: SAFETY.

IDMC recommendation for safety concerns

Phase III Renal Insufficiency, Chronic trial by Biogen. Stop reason: SAFETY.

IDMC recommendation for safety concerns

Phase I Renal Insufficiency, Chronic trial by Biogen. Stop reason: SAFETY.

IDMC recommendation for safety concerns

Phase II End-Stage Renal Disease trial by Biogen. Stop reason: SAFETY.

IDMC recommendation for safety concerns

Phase I Renal Insufficiency, Chronic trial by Biogen. Stop reason: SAFETY.

IDMC recommendation for safety concerns

Phase IV Type 2 Diabetes trial by Meredith Hawkins. Stop reason: OPERATIONAL.

IRB approval expired 6/13/2023. Primary Completion Date and Study Completion Date updated after definitions were explained to PI/study team. Study never reached intended enrollment and will be categorized as terminated.

Phase II New-onset Type 1 Diabetes trial by Dompé Farmaceutici S.p.A. Stop reason: OPERATIONAL.

low recruitment rate

Phase I Type 2 Diabetes Mellitus (T2DM) trial by Alnylam Pharmaceuticals. Stop reason: OPERATIONAL.

Business reasons (not safety related)

Unknown Diabetes Mellitus trial by Graydon Meneilly. Stop reason: OPERATIONAL.

Study was suspended due to current COVID 19 research curtailment

Phase I Secondary Hyperparathyroidism trial by Montefiore Medical Center. Stop reason: OPERATIONAL.

Based on information in IRB archives the study was terminated in 2009 due to low enrollment

Phase I Diabetes Mellitus, Type 2 trial by Janssen Research & Development, LLC. Stop reason: OTHER/UNKNOWN.

manufacturing-related issues

Phase I Diabetes trial by Beijing Suncadia Pharmaceuticals Co., Ltd. Stop reason: OTHER/UNKNOWN.

Sponsor internal strategy change.

Phase IV Prediabetes trial by Gianna Wilkie. Stop reason: OPERATIONAL.

Study was not funded and could not be performed

Phase I Diabetes trial by The Foundation for Orthopaedics and Regenerative Medicine. Stop reason: EFFICACY/FUTILITY.

Due to lack of efficacy

Unknown Polycystic Ovary Syndrome trial by Coordinación de Investigación en Salud, Mexico. Stop reason: OPERATIONAL.

It was not possible to continue recruiting due to SARSCov2 pandemia. Results obtained at that time were already published

Phase II Obesity trial by BioAge Labs, Inc.. Stop reason: OTHER/UNKNOWN.

Dosing of both study drugs has been discontinued due to observation of liver transaminitis without clinically significant symptoms in some subjects receiving azelaprag. All participant visits have been completed.

Phase IV Cystic Fibrosis-related Diabetes trial by University Hospital, Strasbourg, France. Stop reason: OTHER/UNKNOWN.

Difficulties of inclusion in this rare pathology

Phase I Erectile Dysfunction With Diabetes Mellitus trial by University of Miami. Stop reason: OPERATIONAL.

Funding ended

Phase IV Obesity trial by Washington University School of Medicine. Stop reason: OPERATIONAL.

The study was discontinued prematurely for administrative reasons

Early Phase I Maternal Obesity trial by University of Oklahoma. Stop reason: OTHER/UNKNOWN.

Investigator did not return submission for final IRB approval. Study was withdrawn by IRB.

Phase II Type 1 Diabetes trial by Dompé Farmaceutici S.p.A. Stop reason: OPERATIONAL.

low recruitment rate

Phase II Diabetes Mellitus Type 2 in Obese trial by University Hospital, Basel, Switzerland. Stop reason: OPERATIONAL.

Too low recruitment in group with patients with diabetes.

Phase I Type 1 Diabetes trial by Ohio State University. Stop reason: OTHER/UNKNOWN.

Pausing of allotransplant program due to logistic issues.

Phase I Obesity trial by Pfizer. Stop reason: OTHER/UNKNOWN.

The decision to terminate clinical development of lotiglipron is based on pharmacokinetic data from Phase 1 drug-drug-interaction studies and laboratory measurements of elevated transaminases in these Phase 1 studies as well as a Phase 2 study.

Phase IV Overweight and Obesity trial by Yale University. Stop reason: OTHER/UNKNOWN.

PI changed institutions

Phase III Hypercholesterolemia trial by University of Erlangen-Nürnberg Medical School. Stop reason: OTHER/UNKNOWN.

Study was never active