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12 Diseases |  |
138 Trials |
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138 Trials |  |
3994 News |  |
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- ||| Ozempic (semaglutide SC once-weekly) / Novo Nordisk
Enrollment open: A Research Study Looking at the Comparability (Bioequivalence) of Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity (clinicaltrials.gov) - Dec 19, 2019
P1, N=68, Recruiting, Sponsor: Novo Nordisk A/S
Not yet recruiting --> Recruiting
- || Ozempic (semaglutide SC once-weekly) / Novo Nordisk, Byetta (exenatide) / AstraZeneca, semaglutide SC once-daily (NN9536) / Novo Nordisk
Clinical, Review, Journal: Clinical potential of treatment with semaglutide in type 2 diabetes patients. (Pubmed Central) - Dec 19, 2019
First-generation GLP-1RAs were two- or once-daily injectables, but longer-acting GLP-1RAs have now been developed for once-weekly administration - e.g., exenatide ER, dulaglutide and semaglutide...Semaglutide has been compared head-to-head with a dipeptidyl peptidase-4 (DPP4)-inhibitor, GLP-1RAs and basal insulin...There is currently a warning in the Summary of Product Characteristics (SmPC) for semaglutide concerning treatment in patients with preexisting retinopathy. Further studies are needed to clarify this.
- ||||| Victoza (liraglutide) / Novo Nordisk, Ozempic (semaglutide SC once-weekly) / Novo Nordisk
Enrollment closed: STEP 8: Research Study to Investigate How Well Semaglutide Works Compared to Liraglutide in People Living With Overweight or Obesity (clinicaltrials.gov) - Dec 18, 2019
P3, N=337, Active, not recruiting, Sponsor: Novo Nordisk A/S
Further studies are needed to clarify this. Recruiting --> Active, not recruiting
- || Clinical, Journal, HEOR: Oral Semaglutide Versus Empagliflozin, Sitagliptin and Liraglutide in the UK: Long-Term Cost-Effectiveness Analyses Based on the PIONEER Clinical Trial Programme. (Pubmed Central) - Dec 15, 2019
Recruiting --> Active, not recruiting Oral semaglutide was cost-effective versus empagliflozin and sitagliptin, and dominant versus liraglutide, for the treatment of type 2 diabetes in the UK.
- | Ozempic (semaglutide SC once-weekly) / Novo Nordisk
Trial completion date: A Research Study of How Semaglutide Works in People With Disease Affecting the Heart and/or Blood Vessels and Type 2 Diabetes (clinicaltrials.gov) - Dec 9, 2019
P1, N=100, Recruiting, Sponsor: Novo Nordisk A/S
Oral semaglutide was cost-effective versus empagliflozin and sitagliptin, and dominant versus liraglutide, for the treatment of type 2 diabetes in the UK. Trial completion date: May 2021 --> Sep 2021
- ||||| Ozempic (semaglutide SC once-weekly) / Novo Nordisk
Enrollment closed: SUSTAIN 11: A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes (clinicaltrials.gov) - Dec 5, 2019
P3, N=2275, Active, not recruiting, Sponsor: Novo Nordisk A/S
Trial completion date: May 2021 --> Sep 2021 Recruiting --> Active, not recruiting
- ||| Ozempic (semaglutide SC once-weekly) / Novo Nordisk
New P1 trial: A Research Study Looking at the Comparability (Bioequivalence) of Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity (clinicaltrials.gov) - Dec 4, 2019
P1, N=68, Not yet recruiting, Sponsor: Novo Nordisk A/S
- | Ozempic (semaglutide SC once-weekly) / Novo Nordisk
Why does the Ozempic ad say weight loss was “up to 12 pounds on average”? Is 12 the upper bound of a confidence interval? @novonordiskus (Twitter) - Dec 2, 2019
- || Ozempic (semaglutide SC once-weekly) / Novo Nordisk
.@novonordisk I fixed your Ozempic commercial #ozempic (Twitter) - Nov 30, 2019
- ||| Ozempic (semaglutide SC once-weekly) / Novo Nordisk
Enrollment open: A Research Study Looking at Similarity Between Once-weekly Semaglutide Versions for Different Injection Pens (clinicaltrials.gov) - Nov 28, 2019
P1, N=68, Recruiting, Sponsor: Novo Nordisk A/S
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- || semaglutide SC once-daily (NN9536) / Novo Nordisk
Clinical, Journal: Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. (Pubmed Central) - Nov 28, 2019
P3, P4
Most adults with T2D in the United States would have qualified for enrollment into at least 1 of the GLP-1 RA CVOTs evaluated. EXSCEL had the most generalizable eligibility criteria of these trials and ELIXA the least.
- ||| Ozempic (semaglutide SC once-weekly) / Novo Nordisk
Enrollment open, Real-world evidence, Real-world: SURE ITALY: A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Italy, as Part of Local Clinical Practice (clinicaltrials.gov) - Nov 25, 2019
P=N/A, N=520, Enrolling by invitation, Sponsor: Novo Nordisk A/S
EXSCEL had the most generalizable eligibility criteria of these trials and ELIXA the least. Not yet recruiting --> Enrolling by invitation
- | Ozempic (semaglutide SC once-weekly) / Novo Nordisk
New trial, HEOR, Real-world evidence, Real-world: Real-world Health Outcomes in Canadian Patients Using Semaglutide (clinicaltrials.gov) - Nov 24, 2019
P, N=1000, Not yet recruiting, Sponsor: LMC Diabetes & Endocrinology Ltd.
- || Firsocostat (GS-0976) / Gilead, cilofexor (GS-9674) / Gilead
Enrollment closed, Monotherapy: Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Participants With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Nov 22, 2019
P2, N=109, Active, not recruiting, Sponsor: Gilead Sciences
Not yet recruiting --> Enrolling by invitation Recruiting --> Active, not recruiting
- | Ozempic (semaglutide SC once-weekly) / Novo Nordisk
New trial: SWIFT: Semaglutide's Efficacy in Achieving Weight Loss for Those With HIV (clinicaltrials.gov) - Nov 22, 2019
P=N/A, N=80, Not yet recruiting, Sponsor: University College Dublin
- ||| Ozempic (semaglutide SC once-weekly) / Novo Nordisk, cagrilintide (AM833) / Novo Nordisk
Enrollment open, Combination therapy: A Research Study of How NNC0174-0833 Taken With Semaglutide Works in People Who Are Overweight or Obese (clinicaltrials.gov) - Nov 15, 2019
P1, N=96, Recruiting, Sponsor: Novo Nordisk A/S
Recruiting --> Active, not recruiting Active, not recruiting --> Recruiting
- ||| Ozempic (semaglutide SC once-weekly) / Novo Nordisk
Trial completion: A Research Study to Look at How Semaglutide Affects Gastric Emptying in People With Obesity (clinicaltrials.gov) - Nov 15, 2019
P1, N=72, Completed, Sponsor: Novo Nordisk A/S
Active, not recruiting --> Recruiting Active, not recruiting --> Completed
- | Ozempic (semaglutide SC once-weekly) / Novo Nordisk
Journal: Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®) (Pubmed Central) - Nov 8, 2019
Presented as prefilled pens for subcutaneous injection, semaglutide is currently reimbursed in Belgium after failure of antidiabetic therapy including metformin (HbA1c superior to 7,5 % or 58 mmol/mol) in T2D patients with body mass index ? 30 kg/m².
- | Ozempic (semaglutide SC once-weekly) / Novo Nordisk
@novonordisk possibly consider a different song for your Ozempic commercial 🤦♀️😫😫 (Twitter) - Nov 8, 2019
- || Ozempic (semaglutide SC once-weekly) / Novo Nordisk
Enrollment closed, Trial completion date, Trial primary completion date, Real-world evidence, Real-world: A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in United Kingdom, as Part of Local Clinical Practice (SURE UK) (clinicaltrials.gov) - Nov 8, 2019
P=N/A, N=217, Active, not recruiting, Sponsor: Novo Nordisk A/S
30 kg/m². Enrolling by invitation --> Active, not recruiting | Trial completion date: Dec 2020 --> May 2020 | Trial primary completion date: Dec 2020 --> May 2020
- ||| Ozempic (semaglutide SC once-weekly) / Novo Nordisk
New P1 trial: A Research Study Looking at Similarity Between Once-weekly Semaglutide Versions for Different Injection Pens (clinicaltrials.gov) - Nov 4, 2019
P1, N=68, Not yet recruiting, Sponsor: Novo Nordisk A/S
- | Rybelsus (semaglutide oral) / Novo Nordisk, Ozempic (semaglutide SC once-weekly) / Novo Nordisk
Novo preps for Rybelsus 'strike mode' as Ozempic hits blockbuster heights @FiercePharma https://t.co/rllhpu6TFV (Twitter) - Nov 4, 2019
- | Clinical, PK/PD data, Review, Journal: Pharmacokinetics and Clinical Implications of Semaglutide: A New Glucagon-Like Peptide (GLP)-1 Receptor Agonist. (Pubmed Central) - Nov 2, 2019
Based on clinical trials, semaglutide has been compared with placebo, sitagliptin, exenatide extended release, and insulin glargine as monotherapy or add-on therapy...Semaglutide can be another acceptable option for patients with T2DM, and it has a potential role among patients who require weight loss with a low risk of hypoglycemia. This article evaluates the pharmacokinetics of semaglutide and summarizes its application to clinical practice based on efficacy and safety data.
- || LAI287/semaglutide (NN1535) / Novo Nordisk, Ozempic (semaglutide SC once-weekly) / Novo Nordisk, Awiqli (insulin icodec) / Novo Nordisk
Trial completion: A Research Study to Look at How Insulin 287 and Semaglutide Work in the Body of People With Type 2 Diabetes When Taken Alone or Together (clinicaltrials.gov) - Oct 31, 2019
P1, N=30, Completed, Sponsor: Novo Nordisk A/S
This article evaluates the pharmacokinetics of semaglutide and summarizes its application to clinical practice based on efficacy and safety data. Active, not recruiting --> Completed
- | Byetta (exenatide) / AstraZeneca, semaglutide SC once-daily (NN9536) / Novo Nordisk
Review, Journal: Glucagon-Like Peptide-1 Receptor Analogues in Type 2 Diabetes: Their Use and Differential Features. (Pubmed Central) - Oct 29, 2019
The six subcutaneous GLP-1RA formulations (i.e. twice-daily exenatide, once-daily liraglutide and lixisenatide, and once-weekly dulaglutide, exenatide and semaglutide) currently available in the EU and USA have many similarities, but also some unique features and properties...GLP-1RAs are generally well tolerated, with gastrointestinal and injection-site reactions being the most troublesome drug-related adverse events, and are associated with a very low intrinsic risk of hypoglycaemia. Treatment with GLP-1RAs should be customized to meet the clinical needs and personal preferences of the individual.
- | Ozempic (semaglutide SC once-weekly) / Novo Nordisk
Retrospective data, Review, Journal: Comparing once-weekly semaglutide to incretin-based therapies in patients with type 2 diabetes: a systematic review and meta-analysis. (Pubmed Central) - Oct 29, 2019
However, this potent effect of semaglutide was associated with a higher incidence of gastrointestinal side effects. Additional studies are needed to determine whether this marked reduction in both haemoglobin A1c and body weight may translate into improved cardiovascular outcomes.
- | Ozempic (semaglutide SC once-weekly) / Novo Nordisk, Lantus (insulin glargine) / Sanofi
Clinical, Journal, HEOR: Once-weekly semaglutide for patients with type 2 diabetes: a cost-effectiveness analysis in the Netherlands. (Pubmed Central) - Oct 25, 2019
Improvements versus dulaglutide came at a reduced cost from a societal perspective for both doses of once-weekly semaglutide. Once-weekly semaglutide is cost-effective versus insulin glargine U100, and dominant versus dulaglutide 0.75 and 1.5 mg for the treatment of type 2 diabetes, and represents a good use of healthcare resources in the Netherlands.
- | Byetta (exenatide) / AstraZeneca, semaglutide SC once-daily (NN9536) / Novo Nordisk
Review, Journal: Glucagon-Like Peptide-1 Receptor Agonists and Cardiovascular Risk Reduction in Type 2 Diabetes Mellitus: Is It a Class Effect? (Pubmed Central) - Oct 24, 2019
Once-weekly exenatide demonstrated only a non-significant (p = 0.06) favorable trend for CV superiority, possibly due to in-trial mishaps, including placebo drop-ins with other CV protective medications...Maintenance of 24-h circulating levels, by an alternative administration method, may resurrect lixisenatide as a cardioprotective agent. Before a GLP-1 RA bioequivalence "class effect" claim for composite MACE risk reduction superiority can be fully discussed, we are obliged to wait for the pending results of CVOTs with other GLP-1 RAs, particularly albiglutide and dulaglutide, where steric hindrance may potentially inhibit full mimicry of pharmacologic GLP-1.
- | Ozempic (semaglutide SC once-weekly) / Novo Nordisk
Enrollment change, HEOR, Real-world evidence, Real-world: Long Term Comparative Effectiveness of Once Weekly Semaglutide Versus Standard of Care in a Real World Adult US Population With Type 2 Diabetes - a Randomized Pragmatic Trial (clinicaltrials.gov) - Oct 20, 2019
P4, N=1387, Recruiting, Sponsor: Novo Nordisk A/S
Before a GLP-1 RA bioequivalence "class effect" claim for composite MACE risk reduction superiority can be fully discussed, we are obliged to wait for the pending results of CVOTs with other GLP-1 RAs, particularly albiglutide and dulaglutide, where steric hindrance may potentially inhibit full mimicry of pharmacologic GLP-1. N=2250 --> 1387
- | Ozempic (semaglutide SC once-weekly) / Novo Nordisk, semaglutide SC once-daily (NN9536) / Novo Nordisk
Retrospective data, Review, Journal: Orally Administered Semaglutide Versus GLP-1 RAs in Patients with Type 2 Diabetes Previously Receiving 1-2 Oral Antidiabetics: Systematic Review and Network Meta-Analysis. (Pubmed Central) - Oct 11, 2019
Orally administered semaglutide 14 mg QD as an add-on to 1-2 OADs is one of the most efficacious GLP-1 RAs for reducing HbA and body weight at 26 ± 4 weeks. Orally administered semaglutide 14 mg QD is well tolerated, with a safety profile in line with the GLP-1 RA class.
- | Ozempic (semaglutide SC once-weekly) / Novo Nordisk, Farxiga (dapagliflozin) / Ono Pharma, AstraZeneca
Retrospective data, Journal, Monotherapy: Comparative efficacy of once-weekly semaglutide and SGLT-2 inhibitors in type 2 diabetic patients inadequately controlled with metformin monotherapy: a systematic literature review and network meta-analysis. (Pubmed Central) - Oct 9, 2019
Orally administered semaglutide 14 mg QD is well tolerated, with a safety profile in line with the GLP-1 RA class. Once-weekly semaglutide treatment is significantly better compared to SGLT-2is in achieving adequate glycemic control in T2D patients inadequately controlled with metformin monotherapy.
- | Ozempic (semaglutide SC once-weekly) / Novo Nordisk
Enrollment open: A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity (clinicaltrials.gov) - Oct 9, 2019
P3, N=192, Recruiting, Sponsor: Novo Nordisk A/S
Once-weekly semaglutide treatment is significantly better compared to SGLT-2is in achieving adequate glycemic control in T2D patients inadequately controlled with metformin monotherapy. Not yet recruiting --> Recruiting
- | Ozempic (semaglutide SC once-weekly) / Novo Nordisk, Farxiga (dapagliflozin) / Ono Pharma, AstraZeneca
Enrollment open: Triple Therapy in T1DM (clinicaltrials.gov) - Oct 1, 2019
P2/3, N=114, Recruiting, Sponsor: State University of New York at Buffalo
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | Ozempic (semaglutide SC once-weekly) / Novo Nordisk
Enrollment open, Real-world evidence, Real-world: A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in France, as Part of Local Clinical Practice (SURE FRANCE) (clinicaltrials.gov) - Sep 26, 2019
P=N/A, N=217, Enrolling by invitation, Sponsor: Novo Nordisk A/S
Not yet recruiting --> Recruiting Not yet recruiting --> Enrolling by invitation
- | Ozempic (semaglutide SC once-weekly) / Novo Nordisk
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: A Research Study to Compare Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity (clinicaltrials.gov) - Sep 26, 2019
P1, N=29, Terminated, Sponsor: Novo Nordisk A/S
Not yet recruiting --> Enrolling by invitation N=68 --> 29 | Trial completion date: Jun 2020 --> Aug 2019 | Recruiting --> Terminated | Trial primary completion date: Jun 2020 --> Aug 2019; The trial was terminated for strategic reasons.
- | Journal: Semaglutide: The Newest Once-Weekly GLP-1 RA for Type 2 Diabetes. (Pubmed Central) - Sep 26, 2019
N=68 --> 29 | Trial completion date: Jun 2020 --> Aug 2019 | Recruiting --> Terminated | Trial primary completion date: Jun 2020 --> Aug 2019; The trial was terminated for strategic reasons. Semaglutide is an appealing option for the treatment of T2D as a once-weekly GLP-1 RA with established glycemic, CV, and weight benefits.
- | Ozempic (semaglutide SC once-weekly) / Novo Nordisk
New P3 trial: A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity (clinicaltrials.gov) - Sep 24, 2019
P3, N=192, Not yet recruiting, Sponsor: Novo Nordisk A/S
- | Ozempic (semaglutide SC once-weekly) / Novo Nordisk
New trial, Real-world evidence, Real-world: SURE ITALY: A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Italy, as Part of Local Clinical Practice (clinicaltrials.gov) - Sep 18, 2019
P, N=520, Not yet recruiting, Sponsor: Novo Nordisk A/S
- || Ozempic (semaglutide SC once-weekly) / Novo Nordisk, Trulicity (dulaglutide) / Eli Lilly
When your @NortheasternSOP #APPE student asks how you decide between #Trulicity and #Ozempic for #T2DM. #theresatrialforthat Tune in tomorrow for live tweets as @Meissane_B and I review #SUSTAIN7 published in @TheLancet #diabetes #ambcarerx #layeredlearning @BMCPharmRes (Twitter) - Sep 18, 2019
- || Ozempic (semaglutide SC once-weekly) / Novo Nordisk
Ozempic® de @novonordisk ofrece reducciones superiores de los niveles de HbA1c y el peso corporal en comparación con canagliflozina en #pacientes con #diabetestipo2 @CiceroComunica (Twitter) - Sep 18, 2019
- || Victoza (liraglutide) / Novo Nordisk, Ozempic (semaglutide SC once-weekly) / Novo Nordisk, Invokana (canagliflozin) / J&J, Daiichi Sankyo, Mitsubishi Tanabe
Head-to-Head: EASD: Novo's Ozempic tops Victoza, J&J's Invokana in double head-to-head win https://t.co/1eyh8x8OZY (Twitter) - Sep 17, 2019
- | Victoza (liraglutide) / Novo Nordisk, Ozempic (semaglutide SC once-weekly) / Novo Nordisk
Enrollment open: STEP 8: Research Study to Investigate How Well Semaglutide Works Compared to Liraglutide in People Living With Overweight or Obesity (clinicaltrials.gov) - Sep 13, 2019
P3, N=336, Recruiting, Sponsor: Novo Nordisk A/S
Semaglutide is an appealing option for the treatment of T2D as a once-weekly GLP-1 RA with established glycemic, CV, and weight benefits. Not yet recruiting --> Recruiting
- | Ozempic (semaglutide SC once-weekly) / Novo Nordisk
New trial, Real-world evidence, Real-world: A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in France, as Part of Local Clinical Practice (SURE FRANCE) (clinicaltrials.gov) - Sep 9, 2019
P, N=217, Not yet recruiting, Sponsor: Novo Nordisk A/S
- | Ozempic (semaglutide SC once-weekly) / Novo Nordisk, semaglutide SC once-daily (NN9536) / Novo Nordisk
Journal: An Overview of the Burden of Illness and the Role of Once-Weekly Glucagon-like Peptide-1 Receptor Agonists in the Treatment of Type 2 Diabetes. (Pubmed Central) - Sep 7, 2019
Clinical data have been limited on CV outcomes among OW GLP-1 RAs. However, a post hoc analysis of the SUSTAIN-6 trial suggested that semaglutide, the most recently US Food and Drug Administration (FDA)-approved OW GLP-1 RA therapy, may offer cardioprotection, addressing this previously unmet clinical need.
- | Ozempic (semaglutide SC once-weekly) / Novo Nordisk, Januvia (sitagliptin) / Merck (MSD), semaglutide SC once-daily (NN9536) / Novo Nordisk
Clinical, Journal: Clinical Efficacy of Once-weekly Glucagonlike Peptide-1 Receptor Agonists in Patients with Type 2 Diabetes. (Pubmed Central) - Sep 7, 2019
...This review analyzed and compared the efficacy results from 30 trials with the once-weekly (OW) GLP-1 RAs albiglutide, dulaglutide, exenatide extended-release (ER) and semaglutide...OW GLP-1 RAs also offered improved glycemic control when compared with the dipeptidyl peptidase-4 inhibitor sitagliptin. In conclusion, OW GLP-1 RAs offer a valid therapeutic option for T2D.
- | Ozempic (semaglutide SC once-weekly) / Novo Nordisk, Byetta (exenatide) / AstraZeneca, semaglutide SC once-daily (NN9536) / Novo Nordisk
Clinical, Journal: Safety of Once-weekly Glucagon-like Peptide-1 Receptor Agonists in Patients with Type 2 Diabetes. (Pubmed Central) - Sep 7, 2019
...Currently, 4 once-weekly (OW) GLP-1 RAs are approved: albiglutide, dulaglutide, exenatide ER, and recently, semaglutide...The favorable safety profiles of OW GLP-1 RAs, added to their efficacy and the favorable weekly dosing regimen, make these agents appropriate options for patients with T2D. However, there are key differences within this class of drugs in macrovascular, microvascular, gastrointestinal and injection-site reaction adverse events, and these should be considered when healthcare providers are prescribing therapy.
- || Ozempic (semaglutide SC once-weekly) / Novo Nordisk, Trulicity (dulaglutide) / Eli Lilly
Do you have an opinion on Trulicity v. Ozempic? (Twitter) - Sep 1, 2019
- | Victoza (liraglutide) / Novo Nordisk, Ozempic (semaglutide SC once-weekly) / Novo Nordisk
New P3 trial: STEP 8: Research Study to Investigate How Well Semaglutide Works Compared to Liraglutide in People Living With Overweight or Obesity (clinicaltrials.gov) - Aug 29, 2019
P3, N=336, Not yet recruiting, Sponsor: Novo Nordisk A/S
- | Ozempic (semaglutide SC once-weekly) / Novo Nordisk
New trial, Real-world evidence, Real-world: SURE SPAIN: A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Spain, as Part of Local Clinical Practice (clinicaltrials.gov) - Aug 28, 2019
P, N=217, Enrolling by invitation, Sponsor: Novo Nordisk A/S
- | Firsocostat (GS-0976) / Gilead, cilofexor (GS-9674) / Gilead
Enrollment open, Monotherapy: Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Participants With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Aug 26, 2019
P2, N=100, Recruiting, Sponsor: Gilead Sciences
However, there are key differences within this class of drugs in macrovascular, microvascular, gastrointestinal and injection-site reaction adverse events, and these should be considered when healthcare providers are prescribing therapy. Not yet recruiting --> Recruiting