[Translation] A Phase I, open-label, parallel-group, single-dose study evaluating the pharmacokinetics of HTD1801 in subjects with mild to moderate renal impairment and matched controls with normal renal function

首要目的：在轻度和中度肾功能损害受试者与匹配的肾功能正常对照受试者中确定HTD1801的单次给药PK特征。次要目的：1、在轻度和中度肾功能损害受试者与匹配的肾功能正常对照受试者中评估HTD1801的安全性和耐受性；2、在轻度和中度肾功能损害受试者与匹配的肾功能正常对照受试者中评估HTD1801的血浆蛋白结合情况；3、评估基线肾功能与PK参数之间的关系。

[Translation]

Primary objective: To determine the single-dose PK characteristics of HTD1801 in subjects with mild and moderate renal impairment and matched control subjects with normal renal function. Secondary objectives: 1. To evaluate the safety and tolerability of HTD1801 in subjects with mild and moderate renal impairment and matched control subjects with normal renal function; 2. To evaluate the plasma protein binding of HTD1801 in subjects with mild and moderate renal impairment and matched control subjects with normal renal function; 3. To evaluate the relationship between baseline renal function and PK parameters.

Start Date02 Sep 2024

Sponsor / Collaborator

Hightide Therapeutics, Inc.

CTR20242600 / RecruitingPhase 1

[14C-B]HTD1801在健康受试者中的单中心、非随机、开放、单次给药的物质平衡研究

[Translation] [14C-B] A single-center, non-randomized, open-label, single-dose mass balance study of HTD1801 in healthy subjects

主要研究目的： 1) 定量分析男性健康受试者单次口服[14C-B]HTD1801后，排泄物（尿液和粪便）中的总放射性量，获得人体放射性的累积排泄率； 2) 鉴定男性健康受试者单次口服[14C-B]HTD1801后人体内的代谢产物，确定主要生物转化途径和主要代谢产物结构； 3) 考察男性健康受试者单次口服[14C-B]HTD1801后，全血和血浆中总放射性的分配情况以及血浆总放射性的药代动力学。次要研究目的： 1) 采用已验证的液相色谱-串联质谱法（LC-MS/MS）定量分析血浆中的小檗碱及其主要代谢产物（如适用）的浓度，获得小檗碱及其主要代谢产物（如适用）的药动学参数； 2) 评价[14C-B]HTD1801单次给药后男性健康受试者的安全性。

[Translation]

Main study objectives: 1) To quantitatively analyze the total radioactivity in excreta (urine and feces) after a single oral administration of [14C-B]HTD1801 to healthy male subjects, and obtain the cumulative excretion rate of radioactivity in the human body; 2) To identify the metabolites in the human body after a single oral administration of [14C-B]HTD1801 to healthy male subjects, and determine the main biotransformation pathways and the structures of the main metabolites; 3) To investigate the distribution of total radioactivity in whole blood and plasma and the pharmacokinetics of total radioactivity in plasma after a single oral administration of [14C-B]HTD1801 to healthy male subjects. Secondary study objectives: 1) To quantitatively analyze the concentration of berberine and its main metabolites (if applicable) in plasma using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, and obtain the pharmacokinetic parameters of berberine and its main metabolites (if applicable); 2) To evaluate the safety of healthy male subjects after a single administration of [14C-B]HTD1801.

Start Date12 Aug 2024

Sponsor / Collaborator

Hightide Therapeutics, Inc.

NCT06415773 / RecruitingPhase 3

A Phase 3, Multicenter, Randomized, Double-Blind, Active-Controlled (Dapagliflozin), Parallel Group Efficacy and Safety Study of HTD1801 in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone

The goal of this clinical study is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin alone.

Start Date01 May 2024

Sponsor / Collaborator

Hightide Therapeutics, Inc.

[+1]

100 Clinical Results associated with Berberine Ursodeoxycholate

100 Translational Medicine associated with Berberine Ursodeoxycholate

100 Patents (Medical) associated with Berberine Ursodeoxycholate

Literatures (Medical) associated with Berberine Ursodeoxycholate

01 Nov 2022·American Journal of Gastroenterology

A Randomized, Dose-Finding, Proof-of-Concept Study of Berberine Ursodeoxycholate in Patients With Primary Sclerosing Cholangitis

Article

Author: Gunn, Nadege ; Hirschfield, Gideon M. ; Kowdley, Kris V. ; Harrison, Stephen A. ; Forman, Lisa ; Liberman, Alexander ; Di Bisceglie, Adrian M. ; Eksteen, Bertus ; Landis, Charles ; Sundaram, Vinay ; Levy, Cynthia

INTRODUCTION:Primary sclerosing cholangitis (PSC) is a fibroinflammatory disease of the bile ducts leading to cirrhosis and hepatic decompensation. There are no approved pharmaceutical therapies for PSC. Berberine ursodeoxycholate (HTD1801) is an ionic salt of berberine and ursodeoxycholic acid with pleiotropic mechanisms of action.METHODS:An 18-week proof-of-concept study was conducted to assess the safety and efficacy of HTD1801 in PSC. This study had three 6-week periods: (i) a placebo-controlled period, (ii) a treatment extension period, and (iii) a randomized treatment withdrawal period. The primary end point was change from baseline in alkaline phosphatase (ALP) at week 6.RESULTS:Fifty-five patients were randomized and treated; 35 (64%) had inflammatory bowel disease and 22 (40%) had previously received ursodeoxycholic acid. Patients were initially randomized to placebo (n = 16), HTD1801 500 mg BID (n = 15), or HTD1801 1000 mg BID (n = 24). At baseline, mean (range) ALP values were 414 U/L (138–1,048), 397 U/L (237–773), and 335 U/L (122–882) for the placebo, HTD1801 500 mg BID, and HTD1801 1,000 mg BID groups, respectively. At week 6, a significant decrease in ALP was observed with HTD1801 (least square mean; HTD1801 500 mg BID = −53 U/L, P = 0.016; HTD1801 1000 mg BID = −37 U/L, P = 0.019) compared with placebo (98 U/L). ALP reductions were sustained through week 18 in those who remained on therapy, whereas ALP increased in those who crossed over to placebo during period 3. HTD1801 was generally well tolerated; 4 patients experienced serious adverse events, none attributed to HTD1801.DISCUSSION:HTD1801 is associated with significant improvement in ALP and warrants further study as a treatment for PSC.

01 Nov 2022·American Journal of Gastroenterology

Berberine Ursodeoxycholate for the Treatment of Primary Sclerosing Cholangitis: The Search for the Elusive Pharmacologic Holy Grail Will Need to Continue

Article

Author: Yoshida, Eric M.

AbstractEffective pharmacologic treatment of primary sclerosing cholangitis (PSC) remains elusive. Ursodeoxycholic acid (UDCA) is known to improve liver biochemistry, specifically serum alkaline phosphatase, in patients with PSC but has not been shown to favourably alter the natural history. Similarly, many immunomodulatory medications have been studied for the treatment of PSC, but none has been demonstrated to be of unequivocal benefit. In this issue of the Journal, a pilot study of a ursodeoxycholate berberine salt vs placebo is reported. Although improvement in serum alkaline phosphatase is reported, without a control arm with UDCA monotherapy, it is not possible to determine whether this study drug is beneficial over UDCA by itself. More study in the PSC therapeutic arena is needed.

Nature CommunicationsQ1 · CROSS-FIELD

A phase 2, proof of concept, randomised controlled trial of berberine ursodeoxycholate in patients with presumed non-alcoholic steatohepatitis and type 2 diabetes

Q1 · CROSS-FIELD

ArticleOA

Author: Di Bisceglie, Adrian M ; Neff, Guy W ; Kohli, Anita ; Harrison, Stephen A ; Liu, Liping ; Flyer, Abbey ; Gunn, Nadege ; Goldkind, Lawrence

AbstractNon-alcoholic steatohepatitis is frequently associated with diabetes and may cause progressive liver disease. Current treatment options are limited. Here we report on a prospective, randomised, double-blind, placebo-controlled trial of two doses of HTD1801 (berberine ursodeoxycholate, an ionic salt of berberine and ursodeoxycholic acid), versus placebo that was conducted in 100 subjects with fatty liver disease and diabetes (NCT03656744). Treatment was for 18 weeks with a primary endpoint of reduction in liver fat content measured by magnetic resonance imaging proton density fat fraction. Key secondary endpoints included improvement in glycemic control, liver-associated enzymes and safety. The pre-specified primary endpoint was met. Thus, subjects receiving 1000 mg twice a day of berberine ursodeoxycholate had significantly greater reduction in liver fat content than in placebo recipients (mean absolute decrease −4.8% vs. −2.0% (p = 0.011). Compared to placebo, subjects receiving this dose also experienced significant improvement in glycemic control as well as reductions in liver-associated enzymes and significant weight loss. Diarrhea and abdominal discomfort were the most frequently reported adverse events. We conclude that berberine ursodeoxycholate has a broad spectrum of metabolic activity in patients with presumed NASH and diabetes. It is relatively well tolerated and merits further development as a treatment for NASH with diabetes.

News (Medical) associated with Berberine Ursodeoxycholate

05 Jun 2024

·www.biospace.com

HighTide Therapeutics Presents Analyses of Phase 2a MASH Study at the 2024 International Liver Congress, Reinforcing and Further Characterizing the Efficacy and Safety of Berberine Ursodeoxcyholate (HTD1801)

ROCKVILLE, MD and SHENZHEN, CHINA, HighTide Therapeutics, Inc. (Stock Code: 2511.HK), a clinical stage biopharmaceutical company specializing in the development of multi-targeted therapies for chronic liver and metabolic diseases, announced that it will make multiple presentations at the European Association for the Study of the Liver (EASL) Congress, taking place from June 5-8, 2024 in Milan, Italy. The presentations include post-hoc analyses of the Phase 2a clinical study of berberine ursodeoxcyholate (HTD1801), a gut-liver anti-inflammatory metabolic modulator, in patients with metabolic dysfunction-associated steatohepatitis (MASH) and comorbid type 2 diabetes mellitus (T2DM) (NCT03656744). “These data provide additional insight on the potential benefits of HTD1801, a novel, multifunctional therapy being developed for the treatment of patients with MASH and T2DM. The ongoing multi-regional Phase 2b study (CENTRICITY, NCT05623189), now fully enrolled, evaluates the histologic benefit of HTD1801 in this same patient population. We look forward to the results of CENTRICITY which is on track to read out in the first half of 2025,” said Dr. Leigh MacConell, Chief Development Officer of HighTide. “Efficacy of Berberine Ursodeoxycholate (HTD1801) Compared to Ongoing Use of GLP-1 Receptor Agonists in Patients with MASH and T2DM” (Abstract SAT-227, Poster Presented June 8) About the Abstract: As GLP-1 Receptor Agonists (GLP-1RAs) are prominently used in patients with T2DM and gaining attention as a potential treatment for MASH, this post-hoc comparative efficacy analysis evaluated ongoing GLP-1RA use compared to newly initiated HTD1801 treatment. This analysis suggests that HTD1801 provides greater benefit across multiple cardiometabolic endpoints compared to ongoing GLP-1RA use. These findings are important as they suggest that patients with MASH and T2DM, on concomitant GLP-1RA treatment, could achieve additional benefit with HTD1801 in terms of further glucose and lipid lowering as well as weight loss. “Berberine Ursodeoxycholate (HTD1801) Provides a Unique Therapeutic Approach for Patients with Metabolic Liver Disease and Severe Insulin Resistance” (Abstract SAT-225, Poster Presented June 8) About the Abstract: Insulin resistance is a significant risk factor for T2DM, obesity and MASH. HTD1801 enhances the utilization of glucose and fats through activation of AMP-activated protein kinase (AMPK), thereby improving insulin sensitivity. As HTD1801 is under development as a treatment for patients with MASH and T2DM, the objective of this post-hoc analysis was to evaluate the effects of HTD1801 based on degree of insulin resistance. These data demonstrate that HTD1801 can alleviate the metabolic inhibitory effects caused by hyperinsulinemia, leading to even greater metabolic benefits in patients with MASH and more severe insulin resistance and therefore may offer a unique therapeutic approach for individuals with MASH and T2DM. “Time Course of Onset, Incidence, and Prevalence of Gastrointestinal Adverse Events with HTD1801 (Berberine Ursodeoxycholate) in Patients with MASH and T2DM” (Abstract SAT-243, Poster Presented June 8) About the Abstract: The most commonly occurring adverse events (AEs) in studies of HTD1801 across several indications have been mild to moderate gastrointestinal (GI) AEs, primarily diarrhea and nausea. The purpose of this post-hoc analysis was to characterize the time course and severity of GI AEs in patients with MASH and T2DM treated with HTD1801 for 18 weeks. Diarrhea and nausea, the most commonly occurring of GI AEs, followed a trend that was consistent with all reported GI AEs; they showed early onset (within the first 4 weeks), were mild or moderate in severity, and importantly, showed a decreasing incidence and prevalence over the course of treatment. These data demonstrate that with continued treatment with HTD1801, GI tolerability improves supporting its potential for long-term use for the treatment of chronic disease, such as MASH. About HighTide Therapeutics HighTide Therapeutics, Inc. (HKEX: 2511) is a globally integrated biopharmaceutical company focusing on the discovery and development of first-in-class multifunctional multi-targeted therapies with chronic liver and metabolic diseases with significant unmet medical needs. The company is developing multiple clinical assets, including therapy for metabolic dysfunction-associated steatohepatitis (MASH), type 2 diabetes (T2DM), severe hypertriglyceridemia (SHTG), primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC). Berberine ursodeoxycholate (HTD1801), the company’s lead drug candidate, received Fast Track designation from the U.S. FDA for both NASH and PSC, as well as Orphan Drug designation for PSC. In China, HTD1801 has been included in the National Major New Drug Innovation Program under the 13th Five-Year Plan for Major Technology Project. Disclaimer The information contained herein is based solely on events or data available as of the date of this document. Unless required by law, we are under no obligation to update or publicly revise any forward-looking statements or events beyond those anticipated, even if new information, future events, or other circumstances arise after the date of the forward-looking statement. Please review this document carefully and be aware that our actual future performance or results may significantly deviate from expectations. All statements in this document are made as of the publication date and may change considering future developments. For more information, please visit Contact: pr@hightidetx.com

Phase 2Orphan DrugFast Track

11 Jan 2023

·www.biospace.com

HighTide Therapeutics Announces First Patient Dosed in Phase 2b Clinical Study Evaluating HTD1801 in NASH (the CENTRICITY study)

ROCKVILLE, MD and SHENZHEN, CHINA, Jan 11, 2023 - (ACN Newswire) - HighTide Therapeutics Inc. ("HighTide"), a globally integrated clinical-stage biopharmaceutical company developing novel multifunctional therapies for metabolic and digestive diseases, today announced the dosing of the first patient in a Phase 2b clinical study evaluating HTD1801 for the treatment of nonalcoholic steatohepatitis ("NASH"). This double-blind, randomized, placebo-controlled, multicentre Phase 2b study will evaluate the effect of HTD1801, 1250 mg twice daily (BID), compared to placebo BID on histologic improvement in adult subjects with NASH and liver fibrosis who also have type 2 diabetes mellitus ("T2DM") or pre-diabetes. The study will enroll approximately 210 subjects with biopsy-confirmed NASH and evidence of stage 2 or stage 3 liver fibrosis. Subjects will receive HTD1801 for up to 60 weeks. "Nonalcoholic fatty liver disease ("NAFLD") is the most prevalent chronic liver disease worldwide with a global prevalence of 25.2% to 29.8%. Of those with NAFLD, about 20% have NASH. Patients with NASH and T2DM or prediabetes are at increased risk of progressive liver disease and cardiometabolic complications," said Dr. Liping Liu, founder and Chief Executive Officer of HighTide. "This first patient dosing marks a key milestone for the development of HTD1801 for the treatment of patients with NASH, building on data from our Phase 2a study which showed HTD1801 was associated with meaningful improvements in liver fat, markers of liver Injury and fibrosis as well as cardiometabolic factors (HbA1c, lipids, and weight) after 18 weeks." About NASH NASH, a severe form of nonalcoholic fatty liver disease (NAFLD), is a chronic, complex liver disease characterized by hepatitis - inflammation of the liver - and liver cell damage, which can lead to fibrosis of the liver. NASH can also lead to cirrhosis and liver cancer. NASH patients with T2DM or impaired glucose tolerance are more likely to progress to more severe disease and to develop complications that lead to increased mortality. Prevalence of NASH is on the rise and may soon surpass hepatitis C as a cause for liver transplant in the U.S. and Europe. Currently, there are no approved therapies for NASH. About HighTide Therapeutics HighTide is a globally integrated clinical-stage biopharmaceutical company focusing on the discovery and development of novel multifunctional therapies for metabolic and digestive diseases with significant unmet medical needs. The company's lead drug candidate, HTD1801, is a first-in-class new molecular entity, currently in clinical development for the treatment of type 2 diabetes (T2DM), nonalcoholic steatohepatitis (NASH), severe hypertriglyceridemia (SHTG), and primary sclerosing cholangitis (PSC). HTD1801 has received Fast Track designation from the U.S. FDA for both NASH and PSC, as well as Orphan Drug designation for PSC. In China, HTD1801 has been included in the National Major New Drug Innovation Program. For more information, please visit . Contacts Nadia Gao ir@hightidetx.com

Phase 2Orphan DrugFast Track

05 Jan 2023

·www.fiercebiotech.com

Fierce Biotech Fundraising Tracker '23: HighTide washes up $107M; Metagenomi hauls in $100M

We're kicking off 2023 with a new Fierce Biotech Fundraising Tracker to keep the pulse on biotech financing. We've launched a new Fierce Biotech Fundraising Tracker for 2023 to track all the venture capital flowing into the industry. While biotech VC investments in 2022 failed to live up to 2021's banner year, the second half still saw a steady stream of fundraises over $30 million. Now, the industry enters the new year with bated breath, wondering what this year could bring after the swing from high to low. Like last year's tracker, we will continue to include any fundraising rounds north of $30 million. We'll still profile exciting new companies and larger rounds in-depth, but we’re hoping to focus more coverage on clinical trial results, special reports and enterprise stories to give readers insights they can't find elsewhere. January Jan. 5—Ensoma CEO: Emile Nuwaysir, Ph.D. Series: B Amount: $85 million Investors: Co-led by Arix Bioscience and 5AM Ventures, plus F-Prime Capital, Cormorant Asset Management, Viking Global Investors, Takeda Ventures, Inc., SymBiosis, Alexandria Venture Investments, Fred Hutchinson Cancer Center, the Bill & Melinda Gates Foundation, Qatar Investment Authority, Catalio Capital Management, Solasta Ventures and Mirae Asset. Genomic medicines biotech Ensoma has snagged $85 million in a series B, while also sealing an acquisition deal for CRISPR engineering company Twelve Bio. Ensoma plans to use the funds to advance its Engenious in vivo engineered cell therapy platform as well as accelerate its pipeline. The acquisition will expand the Engenious platform and boost Ensoma's ability to develop the next generation of genome editors for new medicines that address rare and prevalent disease. Twelve Bio was seeded by Arix Bioscience. Financial details of the acquisition were not disclosed. Release Jan. 5—HighTide Therapeutics CEO: Liping Liu, Ph.D. Series: C/C+ Amount: $107 million Investors: TCM Healthcare Fund of Guangdong, Yuexiu Fund and Yuthai Fund A strong $107 million financing has swept in for Shenzhen, China-based HighTide Therapeutics, which is pursuing novel multifunctional therapies for metabolic and digestive diseases. The clinical-stage biopharma will use the funds for multiple global development programs, including mid- and late-stage clinical trials. HighTide’s lead asset is HTD1801, under development for complex metabolic and digestive diseases. The treatment is currently being investigated in phase 2 trials for type 2 diabetes, nonalcoholic steatohepatitis and primary sclerosing cholangitis. The company raised a $60 million series B+ round at the end of 2020. Release Jan. 5—Metagenomi CEO: Brian C. Thomas Series: B extension Amount: $100 million Investors: Novo Holdings A/S, Catalio Capital Management, SymBiosis and other unnamed investors The $100 million extension round brings Metagenomi's series B total to a hefty $275 million and comes on the heels of partnerships with Big Pharma Moderna and Ionis Pharmaceuticals. The gene editing company plans to use the new money to advance its lead therapeutic programs through preclinical development and into clinical proof-of-concept studies. The California-based biotech also intends to nominate additional therapeutic targets to its genetic medicines pipeline. Release Jan. 5—Perceive Biotherapeutics CEO: K. Angela Macfarlane Series: B Amount: $78 million Investors: Johnson & Johnson Innovation, Deerfield Management, Braidwell, the Retinal Degeneration Fund and Catalio Capital Management The San Francisco biotech has received a large vote of confidence from Big Pharma J&J's venture arm, which led the series B financing round. The company is focused on developing gene therapies and other treatments for eye diseases with high unmet need. The biotech has identified protective biological targets that they believe they can use to develop therapies for addressing over half of currently untreatable retinal blindness. The new money will go toward advancing programs in geographic atrophy/age-related macular degeneration, glaucoma and other undisclosed disease areas. Release Jan. 4—Belharra Therapeutics CEO: Jeff Jonke Series: A Amount: $50 million Investors: Versant Ventures Belharra emerged from stealth with a total of $130 million in capital thanks to a $50 million series A plus a multi-year collaboration with Genentech. Belharra’s tech boasts a “library” of photoaffinity-based chemical probes, which are commonly used in drug discovery, to explore protein-ligand interactions in the cell. The company is helmed by Jeff Jonker, who previously held upper leadership roles at Ambys Medicines and NGM Biopharmaceuticals. Release Jan. 3—Apnimed CEO: Larry Miller, M.D. Series: C extension Amount: $79.75 million Investors: Alpha Wave Ventures, Sectoral Asset Management, Columbia-Seligman Investments, Tao Capital Partners and other unnamed investors. The Massachusetts-based biotech aiming to treat obstructive sleep apnea (OSA) and related disorders has raised an oversubscribed $79.75 million round that extends its series C financing to a total of $142.25 million. The money will go toward the planned phase 3 trials for Apnimed’s lead candidate, dubbed AD109, that could be the first oral treatment for OSA if approved. The clinical trials are expected to start enrollment in the second quarter of 2023 pending discussions with the FDA. Release

AcquisitionPhase 2Gene Therapy

100 Deals associated with Berberine Ursodeoxycholate

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Indication	Highest Phase	Country/Location	Organization	Date
Cholangitis, Sclerosing	Phase 3	-	Hightide Therapeutics, Inc.	-
Diabetes Mellitus, Type 2	Phase 3	-	Hightide Therapeutics, Inc.	-
Prediabetic State	Phase 2	US	HighTide Biopharma Pty Ltd	27 Dec 2022
Familial Primary Biliary Cirrhosis	Phase 2	CN	Hightide Therapeutics, Inc.	03 Mar 2022
Nonalcoholic Steatohepatitis	Phase 2	US	HighTide Biopharma Pty Ltd	26 Nov 2018
Hypertriglyceridemia	Phase 2	-	Hightide Therapeutics, Inc.	-
Biliary stricture	Discovery	US	HighTide Biopharma Pty Ltd	27 May 2021
Primary Biliary Cholangitis	Discovery	US	HighTide Biopharma Pty Ltd	27 May 2021
Nonalcoholic fatty liver	Discovery	US	HighTide Biopharma Pty Ltd	26 Nov 2018
Hypercholesterolemia	Discovery	AU	HighTide Biopharma Pty Ltd	13 Apr 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04604652 (PRONTO-PBC, CTgov)	Phase 2	Cholangitis \| Biliary stricture \| Primary Biliary Cholangitis	24	HTD1801	foovxtlqgp(yztmxlfhpb) = kjpxdzhagd mhahpmcbkf (bfhgxhcihp, pxdfhozfuj - sdbacqdeth) View more	-	24 Apr 2024
NCT03656744 (NASH_TAG2024) Manual	Phase 2	Diabetes Mellitus, Type 2 \| Nonalcoholic Steatohepatitis	100	HTD18011000 mg BID	(zuckyxepha) = dfuriscugb pwarkwusxc (spzwofxpbc, 27.2) View more	Positive	04 Jan 2024
				HTD1801 500 mg BID	-
HTD1801 (EASD2023)	Phase 2	Diabetes Mellitus, Type 2	113	HTD1801 500 mg BID	(fclgdnjrmv) = 1 patient experienced a TEAE of Grade 1 hypoglycemia ezhttdgync (opsojovvxi ) View more	Positive	03 Oct 2023
				HTD1801 1000 mg BID
NCT03381287 (CTgov)	Phase 1/2	Hypercholesterolemia	50	Placebo to match 1000 mg HTD1801 (Placebo)	mbapplqfgg(pviiphuang) = wktpqxyzdg oycdhfndbg (zqlcbvelaw, kopninxflh - hsqchccgtf) View more	-	03 Mar 2023
				HTD1801 Tablets, 500 mg (HTD1801 250 mg BID)	mbapplqfgg(pviiphuang) = cbmphefnwg oycdhfndbg (zqlcbvelaw, ocvlsbiwov - gqkppbbkmv) View more
HTD1801 (EASL2022)	Not Applicable	Liver Diseases	-	HTD1801	rmivimfqsh(zfrlihqfvj) = substantially enhanced for HTD1801 across the pH range for BBR and at pH 6.5 for UDCA vs BBR-Cl or UDCA alone ichzcmxorn (tgjwnyqnkl ) View more	-	25 Jun 2022
				UDCA
NCT03656744 (Phase 2 study, CTgov)	Phase 2	Diabetes Mellitus, Type 2 \| Nonalcoholic Steatohepatitis \| Nonalcoholic fatty liver	101	HTD1801 (500mg HTD1801, Bid)	lzdkqktcia(zenayzjtfn) = zmofallfda irkizgpvfq (dlgwrgaxyn, hrsulohesf - psckjsbyjh) View more	-	29 Dec 2021
				HTD1801 (1000mg HTD1801, Bid)	lzdkqktcia(zenayzjtfn) = eztxbhoomp irkizgpvfq (dlgwrgaxyn, xwjpolizui - rakllgugpq) View more
NCT03656744 (Pubmed \| Nat Commun)	Phase 2	Diabetes Mellitus, Type 2 \| Nonalcoholic Steatohepatitis	100	HTD1801 (berberine ursodeoxycholate) 1000mg twice a day	(dhzawkhfem) = hbbpxoompu cybkdijcvx (iywpgbmtmh )	Positive	17 Sep 2021
				Placebo	(dhzawkhfem) = pqytwbgczp cybkdijcvx (iywpgbmtmh )
NASH_TAG2021	Phase 2	-	100	BUDCA 500mg BID	(gpdspjivff) = the most frequent adverse events were diarrhea and abdominal discomfort; 7% of BUDCA subjects discontinued study medication due to AEs okkdliaybc (glhidinfir ) View more	Positive	12 Mar 2021
EASL2020	Not Applicable	Nonalcoholic Steatohepatitis \| Hypercholesterolemia	50	HTD1801 500 mg/day	tcjwmyzkjk(brzbqigjhy) = hfdlhlpclt jcnundqfra (sxebymjtfj ) View more	-	27 Aug 2020
				HTD1801 1000 mg/day	tcjwmyzkjk(brzbqigjhy) = huubkmguna jcnundqfra (sxebymjtfj ) View more

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