Clinical trials: Metabolism Disorders
Glycogen Storage Disease Type IA
A Study of Adeno-Associated Virus Serotype 8-Mediated Gene Transfer of Glucose-6-Phosphatase in Patients With Glycogen Storage Disease Type Ia (GSDIa)
The primary objectives of this study are to evaluate the efficacy of DTX401 to reduce or eliminate dependence on exogenous glucose replacement therapy to maintain euglycemia and to maintain or improve the quality of glucose…
- Trial name
- NCT05139316
- Testing
- DTX401, Oral prednisolone
- Where
- 20 sites in United States, Brazil and 7 more
- Volunteers
- 52 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
AMN, AMN Gene Mutation
A Study to Evaluate Administration of SBT101 Gene Therapy in Adult Patients With Adrenomyeloneuropathy (AMN)
This is a Phase 1/2 randomized, blinded, dose-escalation study to evaluate the safety and efficacy of intrathecal (IT) administration of SBT101, a recombinant adeno-associated virus serotype 9 (AAV9) containing a functional copy…
- Conditions
- AMN, AMN Gene Mutation, X-ALD
- Trial name
- PROPEL (NCT05394064)
- Testing
- SBT101 Treatment
- Where
- 2 sites in United States, Netherlands
- Volunteers
- 9 people
- Sponsor
- SwanBio Therapeutics, Inc.
Type 2 Diabetes Mellitus
A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes
The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.
- Trial name
- SURPASS-CVOT (NCT04255433)
- Testing
- Tirzepatide, Dulaglutide
- Where
- 635 sites in United States, Argentina and 29 more
- Volunteers
- 13,299 people
- Sponsor
- Eli Lilly and Company
Glycogen Storage Disease Type IA, Von Gierke's Disease (GSD Type Ia)
Study of Long-Term Safety and Efficacy on Gene Therapy in Glycogen Storage Disease Type Ia
The primary objective of this study is to determine the long-term safety of DTX401 following a single intravenous (IV) dose in adults with GSDIa.
- Trial name
- NCT03970278
- Testing
- No intervention
- Where
- 6 sites in United States, Canada and 2 more
- Volunteers
- 12 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Diabetes, Diabetes Type 2
Safety and Feasibility of Novel Therapy for Duodenal Mucosal Regeneration for Type II Diabetes
This is a multi-center, open-label study to assess the feasibility and preliminary safety of the Endogenex Device for endoscopic duodenal mucosal regeneration in patients with type 2 Diabetes inadequately controlled on 2-3…
- Conditions
- Diabetes, Diabetes Type 2, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders
- Trial name
- REGENT-1-US (NCT05014204)
- Testing
- The Endogenex Device
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- Endogenex, Inc.
Type2 Diabetes, Diabetes Mellitus
A Study to Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin or Basal Insulin or Both
The purpose of this study is to learn more about the safety and efficacy of tirzepatide compared to placebo in children or teenagers with type 2 diabetes taking metformin, or basal insulin, or both.
- Conditions
- Type2 Diabetes, Diabetes Mellitus, Diabetes Mellitus, Type 2, T2D
- Trial name
- SURPASS-PEDS (NCT05260021)
- Testing
- Tirzepatide Dose 1, Tirzepatide Dose 2
- Where
- 51 sites in United States, Australia and 7 more
- Volunteers
- 99 people
- Sponsor
- Eli Lilly and Company
Diabetes Type 2, Diabetes Mellitus
A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes
The main purpose of this study is to compare the effect of the addition of tirzepatide or placebo to titrated basal insulin on glycemic control in Chinese participants with type 2 diabetes.
- Conditions
- Diabetes Type 2, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Disease
- Trial name
- SURPASS-CN-INS (NCT05691712)
- Testing
- Tirzepatide
- Where
- 25 sites in China
- Volunteers
- 257 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Dyslipidemias, High Cholesterol
Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.
This study will be a placebo-controlled, double-blind, randomized, phase 3 study to Evaluate the Efficacy, Safety, and Tolerability of Obicetrapib in Participants with a History of Heterozygous Familial Hypercholesterolemia…
- Conditions
- Dyslipidemias, High Cholesterol, Hypercholesterolemia, Familial Hypercholesterolemia
- Trial name
- BROOKLYN (NCT05425745)
- Testing
- Obicetrapib
- Where
- 96 sites in United States, Canada and 8 more
- Volunteers
- 354 people
- Sponsor
- NewAmsterdam Pharma
Dyslipidemias, Lipid Metabolism Disorders
A Study of LY3561774 in Participants With Mixed Dyslipidemia
This a multicenter, Phase 2b, double-blind, placebo-controlled, parallel group study to provide data on efficacy and safety of LY3561774 administered subcutaneously at various doses in participants with mixed dyslipidemia and on…
- Conditions
- Dyslipidemias, Lipid Metabolism Disorders, Metabolic Diseases, Hyperlipoproteinemia
- Trial name
- PROLONG-ANG3 (NCT05256654)
- Testing
- LY3561774
- Where
- 41 sites in United States, Argentina and 5 more
- Volunteers
- 205 people
- Sponsor
- Eli Lilly and Company
Diabetes Mellitus
Feasibility Study of Finesse for Bolus Prandial Insulin Dosing Compared to Multiple Daily Injections
The purpose of this study is to evaluate that Finesse, for prandial insulin bolusing when used in conjunction with basal insulin, achieves equivalent glycemic control when compared to multiple daily injections and to evaluate its…
- Trial name
- NCT01073566
- Testing
- Finesse, Pen/Syringe (Usual injection device)
- Where
- 5 sites in United States
- Volunteers
- 38 people
- Sponsor
- Calibra Medical, Inc.
Severe Hypertriglyceridemia
Study to Explore the Efficacy and Safety of BIO89-100 (Pegozafermin) in Participants With Severe Hypertriglyceridemia
This study is designed to assess the efficacy, safety, and tolerability of different doses and dose regimens (once weekly [QW] or every 2 weeks [Q2W]), subcutaneous (SC) dosing of BIO89-100 (pegozafermin) compared to placebo in…
- Trial name
- NCT04541186
- Testing
- Pegozafermin
- Where
- 48 sites in United States, Czechia and 2 more
- Volunteers
- 86 people
- Sponsor
- 89bio, Inc.
Diabetes Mellitus, Diabetes Mellitus, Type 2
A Study of Two Doses of Dulaglutide (LY2189265) in Japanese Patients With Type 2 Diabetes
The purpose of this study is to evaluate the efficacy and safety of 2 doses of dulaglutide in Japanese participants with type 2 diabetes. The study duration is approximately 58 weeks.
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Disease
- Trial name
- AWARD-JPN (NCT04809220)
- Testing
- Dulaglutide, Oral antihyperglycemics
- Where
- 44 sites in Japan
- Volunteers
- 591 people
- Sponsor
- Eli Lilly and Company
Type 2 Diabetes
Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes
The Revita™ System is being investigated to assess the ability to improve glycemic control in conjunction with diet and exercise in patients with Type 2 diabetes who are inadequately controlled with oral anti-diabetic…
- Trial name
- NCT03653091
- Testing
- Duodenal Mucosal Resurfacing (DMR)
- Where
- 6 sites in United States
- Volunteers
- 9 people
- Sponsor
- Fractyl Health Inc.
Chronic Diabetic Foot Ulcers
Nu-3 Topical Gel for Treatment of Diabetic Foot Ulcer
A PHASE 2a, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE ESCALATING STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF TOPICALLY APPLIED BISPHOSPHOCIN NU-3 GEL TO CLINICALLY NONINFECTED CHRONIC DIABETIC FOOT…
- Trial name
- NCT05276401
- Testing
- 5% Bisphosphocin Topical Gel, 10% Bisphosphocin Topical Gel
- Where
- 5 sites in United States
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Lakewood-Amedex Inc
Obesity, Overweight
A Study of Tirzepatide (LY3298176) in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Overweight (SURMOUNT-CN)
This is a study of tirzepatide in Chinese participants without Type 2 Diabetes who have obesity or overweight. The main purpose is to learn more about how tirzepatide affects body weight.
- Conditions
- Obesity, Overweight, Metabolism and Nutrition Disorder
- Trial name
- SURMOUNT-CN (NCT05024032)
- Testing
- Tirzepatide
- Where
- 29 sites in China
- Volunteers
- 210 people
- Sponsor
- Eli Lilly and Company
Metabolism and Nutrition Disorder, Obesity
Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome
This trial is conducted globally. The aim of this trial is to investigate the effect of liraglutide for weight management in paediatric subjects with Prader-Willi Syndrome.
- Trial name
- NCT02527200
- Testing
- liraglutide
- Where
- 32 sites in United States, Australia and 6 more
- Volunteers
- 56 people
- Sponsor
- Novo Nordisk A/S
Hypertriglyceridemia, Cardiovascular Diseases
Study of ISIS 678354 (AKCEA-APOCIII-LRx) in Participants With Hypertriglyceridemia and Established Cardiovascular Disease (CVD)
This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, including tolerability, of ISIS 678354 and to assess the efficacy of different doses and dosing regimens of ISIS…
- Trial name
- NCT03385239
- Testing
- ISIS 678354
- Where
- 31 sites in United States, Canada
- Volunteers
- 114 people
- Sponsor
- Akcea Therapeutics
Diabetes Mellitus, Type 1, Diabetes Mellitus
Diamyd Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes
The objective of DIAGNODE-2 is to evaluate the efficacy of Diamyd compared to Placebo, upon administration directly into a lymph node in combination with an oral vitamin D/Placebo regimen, in terms of preserving endogenous…
- Conditions
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Autoimmune Diseases, Metabolic Disease
- Trial name
- NCT03345004
- Testing
- Diamyd, Vitamin D
- Where
- 18 sites in Czechia, Netherlands and 2 more
- Volunteers
- 109 people
- Sponsor
- Diamyd Medical AB
GSD1
Safety and Dose-Finding Study of DTX401 (AAV8G6PC) in Adults With Glycogen Storage Disease Type Ia (GSDIa)
The primary objective of the study is to determine the safety of single doses of DTX401, including the incidence of dose-limiting toxicities (DLTs) at each dose level.
- Trial name
- NCT03517085
- Testing
- DTX401, steroid regimen
- Where
- 6 sites in United States, Canada and 2 more
- Volunteers
- 12 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Dyslipidemias, Hyperlipidemias
A Dose-Ranging Study With Vupanorsen (TRANSLATE-TIMI 70)
This is a multicenter, Phase 2b, double-blind, placebo-controlled, parallel group study to provide data on efficacy, safety, tolerability, and pharmacokinetics (PK) of PF-07285557 (hereafter, vupanorsen) administered…
- Conditions
- Dyslipidemias, Hyperlipidemias, Hyperlipoproteinemias
- Trial name
- NCT04516291
- Testing
- Vupanorsen
- Where
- 114 sites in United States, Canada and 1 more
- Volunteers
- 286 people
- Sponsor
- Pfizer