Clinical trials: Metabolic Biomarkers
Post Menopausal Osteoporosis
SUMMIT Study: A Study of Persistence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis.
This 2 arm study will assess the impact of bone marker feedback, using blood sampling and communication of results at week 5, on persistence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis.
- Trial name
- NCT00545480
- Testing
- ibandronate [Bonviva/Boniva]
- Where
- 190 sites in France
- Volunteers
- 596 people
- Sponsor
- Hoffmann-La Roche
Mucopolysaccharidosis II
A Study of Potential Treatment-Responsive Biomarkers and Clinical Outcomes in Hunter Syndrome
This is a six-part prospective, multicenter, multiregional observational study of patients with mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome, to assess biomarkers potentially related to disease severity…
- Trial name
- NCT04007536
- Testing
- No Intervention
- Where
- 6 sites in United States, Netherlands and 1 more
- Volunteers
- 18 people
- Sponsor
- Denali Therapeutics Inc.
Osteopenia, Low Bone Density
Evaluation of the Effect of Spry Belt Treatment on Bone Turnover Marker Profile
To conduct a sham-controlled study to rigorously evaluate the effect of Spry Belt treatment on key bone turnover markers (BTMs) over a 12-week period.
- Trial name
- NCT05457036
- Testing
- Spry Belt
- Where
- 2 sites in United States
- Volunteers
- 94 people
- Sponsor
- Bone Health Technologies, Inc.
Diabetes, Diabetes Mellitus, Type 1
An Observational Study to Assess Longitudinal Variation of Immune Biomarkers in Subjects at Risk for Development of Type 1 Diabetes
This study is conducted in the United States of America (USA). The aim of the study is to assess longitudinal variation of immune biomarkers in subjects at risk for development of type 1 diabetes (T1D).
- Trial name
- NCT01846312
- Testing
- No treatment given
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Morbid Obesity, Metabolic Disease
Study Evaluating Metabolic Syndrome in Subjects Undergoing Gastric Bypass Bariatric Syndrome
Metabolic syndrome is rapidly emerging as an epidemic of global proportions and its definition is still evolving. Patients with this syndrome are at increased risk for cardiovascular disease, and at increased risk of mortality…
- Trial name
- NCT00283374
- Testing
- Laparoscopic Roux-en-Y Gastric Bypass
- Where
- 17 sites in United States, Italy and 1 more
- Volunteers
- 120 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Krabbe Disease
Biomarker for Krabbe Disease (BioKrabbe)
Development of a new MS-based biomarker for the early and sensitive diagnosis of Krabbe Disease from blood
- Trial name
- BIOKRABBE (NCT01425489)
- Where
- 5 sites in Egypt, Germany and 2 more
- Sponsor
- CENTOGENE GmbH Rostock
Non-Alcoholic Fatty Liver Disease
A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE)
A 52-Week, Multi-center, Open-label, Active Treatment Extension Study to Evaluate Safety and Tolerability of Once Daily, Oral Administration of Resmetirom (MGL-3196)
- Trial name
- NCT04951219
- Testing
- Resmetirom
- Where
- 76 sites in United States, Puerto Rico
- Volunteers
- 810 people
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Weight Management, Diet Conditions
A to Z Study Follow-up: Collection of DNA Data From Buccal Swabs
The goal of this study is to determine the association between genotypes and diet. The weight and weight loss data are already available from the previously completed study called: A to Z Study - Benefits and Risks of Alternative…
- Conditions
- Weight Management, Diet Conditions, Dietary Recommendations, Overweight Management
- Trial name
- NCT00866151
- Where
- United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Interleukin Genetics, Inc.
Alzheimer Disease, Mild Cognitive Impairment
Clinical Feasibility of Speech Phenotyping for Remote Assessment of Neurodegenerative and Psychiatric Disorders
The primary objective of the study is to evaluate the feasibility of eliciting continuous narrative speech in different neurodegenerative and psychiatric indications, using remote, self-administered speech tasks, as measured by…
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Dementia With Lewy Bodies, Dementia, Vascular
- Trial name
- RHAPSODY (NCT04939818)
- Where
- 2 sites in United Kingdom
- Volunteers
- 172 people, healthy volunteers welcome
- Sponsor
- Novoic Limited
Autism Spectrum Disorder, Developmental Disorder
Children's Autism Metabolome Project
Development and Clinical Evaluation of the Stemina Metabolic Biomarker-Based Test to Diagnose Autism Spectrum Disorder in Early Childhood.
- Trial name
- CAMP-01 (NCT02548442)
- Where
- 8 sites in United States
- Volunteers
- 1,102 people, healthy volunteers welcome
- Sponsor
- Stemina Biomarker Discovery, Inc.
Type 2 Diabetes, Diabetes (DM)
Detecting Type 2 Diabetes From Voice
The goal of this observational study is to learn if computer analysis of voice recordings can detect Type 2 diabetes in adults. The main questions it aims to answer are: Can advanced voice analysis accurately identify…
- Conditions
- Type 2 Diabetes, Diabetes (DM), T2DM, T2DM (Type 2 Diabetes Mellitus)
- Trial name
- NCT07421921
- Where
- United Kingdom
- Volunteers
- 7,319 people, healthy volunteers welcome
- Sponsor
- Thymia Limited
Prediabetes
Explorative Assessment of Biomarkers in Overweight and Obese Subjects
The rationale for this trial is to apply a simple and minimally strenuous pre-screening approach prior to performing more extensive trial-specific screening and baseline-characterization activities in the resulting pre-selected…
- Trial name
- NCT01910051
- Where
- Germany
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Profil Institut für Stoffwechselforschung GmbH
Calcium, Osteoporosis
A Study of Amorphous Calcium Carbonate in Postmenopausal Women
Using the FREEDOM substudy as a benchmark, evaluate the effects of amorphous calcium carbonate (ACC) on bone mineral density (BMD) in postmenopausal women, both with and without the combination of Denosumab treatment.
- Conditions
- Calcium, Osteoporosis, Bone Mineral Density, Bone Turnover Marker
- Trial name
- NCT06728462
- Testing
- Amorphous calcium carbonate
- Where
- Taiwan
- Volunteers
- 205 people
- Sponsor
- Universal Integrated Corp.
Iron Deficiencies
Impact of Two Iron Formulations on Iron Biomarkers and Quality of Life
This double-blind parallel pilot study will evaluate the safety and efficacy of two Qualia Iron formulations versus placebo in approximately 40 healthy adults (aged 18+) over a 56-day period.
- Trial name
- NCT07156526
- Testing
- Qualia Iron Version A, Qualia Iron Version B
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Qualia Life Sciences
Advanced Solid Tumors
A Phase 1/2 Trial SRA737 in Combination With Gemcitabine and Cisplatin or Gemcitabine Alone in Advanced Cancer Subjects
The purpose of this clinical study is to establish the safety profile, determine the maximum tolerated dose (MTD) and recommend a Phase 2 dose (RP2D) and schedule of SRA737 in combination with low dose gemcitabine; and to…
- Trial name
- NCT02797977
- Testing
- SRA737, gemcitabine, cisplatin, SRA737, gemcitabine
- Where
- 20 sites in Spain, United Kingdom
- Volunteers
- 153 people
- Sponsor
- Sierra Oncology LLC - a GSK company
Lysosomal Storage Diseases, Gaucher Disease
Lyso-Gb1 as a Long-term Prognostic Biomarker in Gaucher Disease
International, multicenter, epidemiological study to demonstrate the correlation and predictive value of lyso-Gb1 concentration with the clinical severity of naïve, initially non-ERT/SRT Gaucher disease type 1 and during the…
- Conditions
- Lysosomal Storage Diseases, Gaucher Disease, Sphingolipidoses
- Trial name
- LYSO-PROOF (NCT02416661)
- Where
- 8 sites in Albania, Greece and 5 more
- Volunteers
- 299 people
- Sponsor
- CENTOGENE GmbH Rostock
Friedreich Ataxia
A Study to Assess Variation in Potential Biomarkers in Friedreich Ataxia
To test the variability of specific ribonucleic acid (RNA) and proteins as well as frataxin levels in samples of blood and buccal cells taken directly from patients with Friedreich's ataxia (FRDA) in order to confirm potential…
- Trial name
- NCT04255680
- Testing
- Buccal Swabs and Blood Draws
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Larimar Therapeutics, Inc.
Diabetes
A Comparison of Measurements of Ketone Body Flux Versus Ketone Body Concentration as a Pharmacodynamic Marker of Hepatic Fatty Acid Oxidation (0000-110)
This study will compare two approaches to the measurement of fatty acid oxidation (ketone body flux and ketone body concentration) and determine which method demonstrates superior sensitivity and variability in the detection of…
- Trial name
- NCT00860392
- Testing
- Stable isotope tracer (13-C(4)-BHB)
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Amyotrophic Lateral Sclerosis
A Safety and Biomarker Study of ALZT-OP1a in Subjects With Mild-Moderate ALS Disease
This is a Phase IIa, randomized, open-label, multi-center, multi-dose study for subjects with mild to moderate ALS. The protocol is designed to determine whether ALZT-OP1a treatment will positively impact neuro-inflammatory…
- Trial name
- NCT04428775
- Testing
- ALZT-OP1a (cromolyn)
- Where
- 6 sites in United States
- Volunteers
- 12 people
- Sponsor
- AZTherapies, Inc.
Celiac Disease
Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients
This study is to characterize the safety and tolerability of an investigational drug called DONQ52 and consists of a single ascending dose part (Part A) and a multiple ascending dose part (Part B) in well-controlled celiac…
- Trial name
- NCT05425446
- Testing
- DONQ52
- Where
- 21 sites in United States, Australia
- Volunteers
- 56 people
- Sponsor
- Chugai Pharmaceutical