A Randomized, Double-blind, Placebo-controlled Mechanistic Study to Evaluate the Effect of HTD1801 in Delaying the Progression of Renal Impairment in Patients With Type 2 Diabetes and Chronic Kidney Disease.

Goal: The goal of this clinical trial is to learn if the investigational drug HTD1801 can slow the progression of kidney damage in adults diagnosed with both Type 2 Diabetes (T2DM) and Chronic Kidney Disease (CKD).
Main Question it Aims to Answer:
▪ Does HTD1801 result in a greater reduction (or a smaller increase) in urine albumin-to-creatinine ratio (UACR) compared to a placebo?
Researchers will compare the group receiving HTD1801 to the group receiving a placebo to see if HTD1801 is more effective in slowing kidney function decline.
Participants will:
* Undergo screening tests to determine eligibility.
* Be randomly assigned to receive either HTD1801 capsules or matching placebo capsules twice daily for 12 weeks.
* Take the study medication twice daily for 12 weeks.
* Attend scheduled clinic visits (weekly for the first 4 weeks, then every 4 weeks) for assessments and check-ups.
* Have their safety monitored through reporting of any health changes and routine lab tests.

Start Date09 Jul 2026

Sponsor / Collaborator

Institute of Biomedical Engineering, Chinese Academy of Medical Sciences

[+2]

CTR20242631

/ CompletedPhase 1

一项在轻、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价HTD1801药代动力学的I期、开放标签、平行组、单次给药研究

[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

/ CompletedPhase 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.

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

23 Jun 2026·NEJM evidence

HTD1801 in Combination with Metformin for Type 2 Diabetes

Article

Author: MacConell, Leigh ; Cheng, Zhifeng ; Shi, Xiaoguang ; Ji, Linong ; Liu, Dexue ; Wang, Xiaomei ; Lin, Yang ; Liu, Yan ; Yu, Meng ; Liu, Liping ; Dong, Xiaolin ; Zhang, Xin ; Gan, Shenglian ; Liu, Kui ; Ma, Jianhua ; Yang, Mingming ; Cai, Hanqing

BACKGROUND:

HTD1801 is an anti-inflammatory metabolic modulator being developed to treat type 2 diabetes (T2D). The safety and efficacy of HTD1801 as an add-on to metformin among patients with T2D with inadequate glycemic control despite stable metformin use have not been well evaluated.

METHODS:

This phase 3 double-blind trial included patients with T2D, glycated hemoglobin (HbA1c) 7.0% to 10.5%, fasting glucose levels of 250.5 mg/dl or lower, and stable use of metformin for 8 weeks or more. Patients were randomly assigned 2:1 to receive either HTD1801 1000 mg orally twice daily (n=365) or placebo (n=184) in addition to their prior metformin treatment. The primary end point was change in HbA1c from baseline to week 24. Data on adverse events were collected during this 24-week time frame.

RESULTS:

The mean HbA1c was 8.6% at baseline and 7.4% at 24 weeks in the HTD1801 group (mean change, -1.2 percentage points; 95% confidence interval [CI], -1.3 to -1.1). The mean HbA1c was 8.5% at baseline and 7.8% at 24 weeks in the placebo group (mean change, -0.7 percentage point; 95% CI, -0.8 to -0.6). The adjusted least-squares mean difference between groups for the change in HbA1c from baseline to week 24 was -0.5 (95% CI, -0.7 to -0.4; P<0.0001). Diarrhea was the most common adverse event (HTD1801, 23.8%; placebo, 1.1%), with three cases in the HTD1801 group graded as severe, and all the other cases being mild to moderate in severity. No patients experienced severe hypoglycemia.

CONCLUSIONS:

After 24 weeks, HbA1c reduction was significantly greater among patients with T2D taking metformin and randomly assigned to receive HTD1801 versus placebo. A higher proportion of patients in the HTD1801 group experienced mild to moderate diarrhea compared with the placebo group. (Funded by Shenzhen HighTide Biopharmaceutical; ClinicalTrials.gov number, NCT06353347.).

01 Apr 2026·Clinical and Molecular Hepatology

Letter to the editor on “HTD1801 demonstrates promising potential for histologic improvements in metabolic dysfunction-associated steatohepatitis in both a preclinical and phase 2 study”

Article

Author: Gao, Xi-Lin

01 Apr 2026·Clinical and Molecular Hepatology

“Surrogates without substance?” Questioning the evidence for histologic improvement with HTD1801: Letter to the editor on “HTD1801 demonstrates promising potential for histologic improvements in metabolic dysfunction-associated steatohepatitis in both a preclinical and phase 2 study”

Article

Author: Lei, Zhihao

News (Medical) associated with Berberine Ursodeoxycholate

30 Jan 2025

·www.prnewswire.com

Metabolic Dysfunction-Associated Steatohepatitis Market to Register Stunning Growth at a CAGR of 17.9% in the US by 2034 | DelveInsight

The MASH treatment landscape is evolving rapidly, driven by a diverse array of therapeutic classes, each with unique mechanisms and potential impacts. The forecast period reveals significant shifts and emerging trends that will shape future market dynamics. LAS VEGAS, Jan. 30, 2025 /PRNewswire/ -- DelveInsight's Metabolic Dysfunction-Associated Steatohepatitis Market Insights report includes a comprehensive understanding of current treatment practices, MASH emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Metabolic Dysfunction-Associated Steatohepatitis Market Report According to DelveInsight's analysis, the market size for MASH was found to be USD 2.1 billion in the 7MM in 2023. In 2023, there were an estimated 42 million prevalent cases of MASH in the 7MM. Out of these, a total of ~15 million cases were diagnosed, and this number is projected to increase by the end of 2034 in the 7MM. Leading MASH companies such as Inventiva Pharma, Novo Nordisk A/S, Cirius Therapeutics, Akero Therapeutics, 89bio, Boehringer Ingelheim, Zealand Pharma, Galectin Therapeutics, Lipocine, Viking Therapeutics, Eli Lilly and Company, Boston Pharmaceuticals, Pfizer, HighTide Biopharma, CytoDyn, Merck & Co., Hanmi Pharmaceutical, Hepagene (Shanghai), Hepion Pharmaceuticals, Enyo Pharmaceuticals, Gilead Sciences, Poxel SA, Zydus Therapeutics, Sagimet Biosciences, Ionis Pharmaceuticals, Corcept Therapeutics, and others are developing novel MASH drugs that can be available in the MASH market in the coming years. The promising MASH therapies in the pipeline include Lanifibranor (IVA337), Semaglutide, Azemiglitazone (MSDC-0602K), Efruxifermin (EFX), BIO89-100 (Pegozafermin), Survodutide (BI 456906), GR-MD-02 (Belapectin), LPCN1144, VK2809, Tirzepatide, BOS-580, Ervogastat (PF-06865571) + Clesacostat (PF-05221304), HTD1801, Leronlimab (PRO 140), Efinopegdutide, HPG1860, Rencofilstat (CRV431), EYP001 (Vonafexor), Semaglutide/Cilofexor/Firsocostat, PXL065, Saroglitazar Magnesium, Denifanstat (TVB-2640), ION224, Miricorilant (CORT118335), and others. In March 2024, Madrigal Pharmaceuticals' groundbreaking product, REZDIFFRA (resmetirom), a once-daily, oral THR-ß agonist, received accelerated endorsement from the US FDA based on results from the Phase III MAESTRO-NASH trial. This approval marks a significant stride in the medical landscape, as REZDIFFRA becomes the inaugural and sole FDA-sanctioned therapy for adults afflicted with non-cirrhotic MASH, accompanied by moderate to advanced liver scarring (fibrosis) corresponding to stages F2–F3 fibrosis. Discover which therapies are expected to grab the major MASH market share @ Metabolic Dysfunction-Associated Steatohepatitis Market Report Metabolic Dysfunction-Associated Steatohepatitis Overview Metabolic dysfunction-associated steatohepatitis (MASH) is a progressive liver disease that stems from metabolic dysfunction, often linked to obesity, diabetes, and other conditions of metabolic syndrome. MASH is characterized by the accumulation of fat in liver cells, accompanied by inflammation and liver cell injury, which can progress to fibrosis, cirrhosis, or even liver cancer. The primary drivers of MASH include insulin resistance, obesity, type 2 diabetes, and dyslipidemia. Genetic predisposition and a sedentary lifestyle also play significant roles. Environmental factors, such as a poor diet high in sugars and fats, exacerbate the condition. MASH is often asymptomatic in its early stages. When symptoms occur, they can include fatigue, vague abdominal discomfort, or pain in the upper right quadrant. In advanced stages, signs of liver dysfunction such as jaundice, swelling of the abdomen or legs, and confusion may arise. Diagnosis involves a combination of clinical history, physical examination, and diagnostic tests. Blood tests measuring liver enzymes (ALT, AST) often indicate liver inflammation. Imaging techniques like ultrasound, MRI, or FibroScan can identify liver fat and fibrosis. In some cases, a liver biopsy is required to confirm the diagnosis and assess disease severity. Metabolic Dysfunction-Associated Steatohepatitis Epidemiology Segmentation The MASH epidemiology section provides insights into the historical and current MASH patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The MASH market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Prevalent Cases of MASH Diagnosed Prevalent Cases of MASH Gender-specific Diagnosed Prevalent Cases of MASH Severity-specific Diagnosed Prevalent Cases of MASH Metabolic Dysfunction-Associated Steatohepatitis Treatment Market The approval of REZDIFFRA (resmetirom) in March 2024 represents a pivotal achievement in medical innovation, transforming the treatment landscape for MASH disease. This groundbreaking therapy addresses the root causes of MASH, offering renewed hope to patients grappling with this challenging condition. Clinical trials have shown impressive results, with REZDIFFRA effectively reducing symptoms like inflammation and fibrosis, enhancing liver function, and improving patients' quality of life. By providing healthcare professionals with a robust treatment option, this approval addresses a critical unmet need and has the potential to significantly alleviate the complications linked to advanced liver disease. The prevalence of MASLD is strongly linked to type 2 diabetes mellitus and obesity, particularly in individuals with a higher body mass index. However, MASLD occurrence is reduced in T2DM patients receiving treatments such as sodium-glucose cotransporter-2 (SGLT2) inhibitors, GLP-1 receptor agonists, and insulin. Vitamin E, with its antioxidant properties, is regarded as a first-line pharmacological option for managing MASH, especially when dietary and lifestyle interventions are insufficient. Antifibrotic agents can help prevent the progression of liver fibrosis and MASLD into fibrotic MASH. The role of pioglitazone, an anti-diabetic medication, in improving MASH histology in T2DM patients is well-documented, but concerns remain regarding potential side effects like weight gain, fluid retention, cancer risk, and bone fractures. Additional therapeutic targets for MASLD and MASH include G protein-coupled receptors (GPCRs), estrogen-related receptor alpha (ERRα), bone morphogenetic proteins (BMPs), and KLFs. Bariatric surgery, or weight loss surgery, is the most effective intervention for treating obesity and diabetes, as it reduces food absorption while influencing gut hormone secretion and metabolic function. To know more about MASH treatment guidelines, visit @ Metabolic Dysfunction-Associated Steatohepatitis Management Metabolic Dysfunction-Associated Steatohepatitis Pipeline Therapies and Key Companies Lanifibranor (IVA337): Inventiva Pharma Semaglutide: Novo Nordisk A/S Azemiglitazone (MSDC-0602K): Cirius Therapeutics Efruxifermin (EFX): Akero Therapeutics BIO89-100 (Pegozafermin): 89bio Survodutide (BI 456906): Boehringer Ingelheim/Zealand Pharma GR-MD-02 (Belapectin): Galectin Therapeutics LPCN1144: Lipocine VK2809: Viking Therapeutics Tirzepatide: Eli Lilly and Company BOS-580: Boston Pharmaceuticals Ervogastat (PF-06865571) + Clesacostat (PF-05221304): Pfizer HTD1801: HighTide Biopharma Leronlimab (PRO 140): CytoDyn Efinopegdutide: Merck & Co./Hanmi Pharmaceutical HPG1860: Hepagene (Shanghai) Rencofilstat (CRV431): Hepion Pharmaceuticals EYP001 (Vonafexor): Enyo Pharmaceuticals Semaglutide/ Cilofexor/ Firsocostat: Gilead Sciences PXL065: Poxel SA Saroglitazar Magnesium: Zydus Therapeutics Denifanstat (TVB-2640): Sagimet Biosciences ION224: Ionis Pharmaceuticals Miricorilant (CORT118335): Corcept Therapeutics Discover more about MASH drugs in development @ Metabolic Dysfunction-Associated Steatohepatitis Clinical Trials Metabolic Dysfunction-Associated Steatohepatitis Market Dynamics The MASH market dynamics are expected to change in the coming years. Growing research activities and multiple clinical trials for MASH, driven by the rapid surge in its prevalence due to rising obesity and type 2 diabetes rates, highlight an active drug development pipeline and an expanding market size. The large pool of patients and lucrative growth opportunities present attractive prospects for key players, further supported by ongoing preclinical studies aimed at advancing imaging techniques for MASH diagnosis, potentially eliminating the need for invasive biopsy-based histopathological confirmation. Furthermore, potential therapies are being investigated for the treatment of MASH, and it is safe to predict that the treatment space will significantly impact the MASH market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the MASH market in the 7MM. However, several factors may impede the growth of the MASH market. Lack of awareness and negligence in the early stages of MASH by physicians often lead to disease progression, culminating in irreversible damage where liver transplantation becomes the only viable option. Diagnosing advanced MASH typically requires procedures like liver biopsy, which are costly, invasive, and risky. Regulatory challenges also pose hurdles, as the FDA mandates achieving one MASH endpoint for approval, while the EMA's draft guidance requires efficacy in both endpoints, potentially delaying first-mover approvals in major European markets. Additionally, access to expensive MASH treatments may be limited in certain regions, further hindering patient adoption. Moreover, MASH treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, MASH market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact MASH market growth. Scope of the Metabolic Dysfunction-Associated Steatohepatitis Market Report Therapeutic Assessment: Metabolic Dysfunction-Associated Steatohepatitis current marketed and emerging therapies Metabolic Dysfunction-Associated Steatohepatitis Market Dynamics: Key Market Forecast Assumptions of Emerging Metabolic Dysfunction-Associated Steatohepatitis Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Metabolic Dysfunction-Associated Steatohepatitis Market Access and Reimbursement Download the report to understand which factors are driving MASH market trends @ Metabolic Dysfunction-Associated Steatohepatitis Market Trends Table of Contents Related Reports Non-Alcoholic Steatohepatitis Epidemiology Forecast Non-Alcoholic Steatohepatitis Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted NASH epidemiology in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, Spain), the United Kingdom, and Japan. Nonalcoholic Steatohepatitis Pipeline Nonalcoholic Steatohepatitis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key nonalcoholic steatohepatitis companies, including Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Cirius Therapeutics, Novo Nordisk, Inventiva, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, 89bio, Inc., Eccogene, Novartis Pharmaceuticals, Poxel SA, AngioLab, Pfizer, Arrowhead Pharma, LG Chem, Redx Pharma, Lipocine, Inc., CytoDyn, Inc., Alnylam Pharmaceuticals, Inc., Chemomab Therapeutics, NuSirt Biopharma, HK inno. N, Aligos Therapeutics, Altimmune, Inc., Kowa Pharmaceutical, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Hanmi Pharmaceutical, Hepagene Therapeutics, HighTide Biopharma, Akero Therapeutics, Merck Sharp & Dohme LLC, Cascade Pharmaceuticals, Hepion Pharmaceuticals, Chipscreen Biosciences, Boston Pharmaceuticals, Bristol-Myers Squibb, Sunshine Lake Pharma, GSK plc., Future Medicine, Gilead Sciences, ENYO Pharma, Histogen, among others. Non-Alcoholic Fatty Liver Disease Market Non-Alcoholic Fatty Liver Disease Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key NAFLD companies, including MediciNova, Eli Lilly and Company, AstraZeneca, Inventiva Pharma, Oasis Pharmaceuticals, LLC, Madrigal Pharmaceuticals, Inc., BioMarin Pharmaceutical, GlaxoSmithKline, Zydus Therapeutics Inc., Akero Therapeutics, Inc, Pfizer, Boehringer Ingelheim, Neuraly, Inc., Merck Sharp & Dohme LLC, Rivus Pharmaceuticals, Inc., Hepion Pharmaceuticals, Inc. , among others. Non-Alcoholic Fatty Liver Disease Pipeline Non-Alcoholic Fatty Liver Disease Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key NAFLD companies, including BeiGene, Inventiva Pharma, Cirius Therapeutics, Madrigal Pharma, Novo Nordisk, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Dr. Falk Pharma GmbH, Sagimet Biosciences, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, Novartis Pharmaceuticals, Afimmune, Poxel SA, AngioLab, Pfizer, Oramed Pharmaceuticals, Can Fite Biopharma, MediciNova, Metacrine, Inc., Lipocine, Inc., CytoDyn, Inc., Alnylam Pharmaceuticals, Inc., Mitsubishi Tanabe Pharma, Chemomab Therapeutics, NuSirt Biopharma, HK inno.N, Kowa Pharmaceutical, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Hanmi Pharmaceutical, Hepagene Therapeutics, HighTide Biopharma, Akero Therapeutics, Enanta Pharmaceuticals, Cascade Pharmaceuticals, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3

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

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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

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	NDA/BLA	China	Hightide Therapeutics, Inc.	09 Mar 2026
Diabetes Mellitus, Type 2	NDA/BLA	China	WUXI APPTEC, INC	09 Mar 2026
Cholangitis, Sclerosing	Phase 3	Global	Hightide Therapeutics, Inc.	-
Chronic Kidney Diseases	Phase 2	China	Hightide Therapeutics, Inc.	09 Jul 2026
Fibrosis, Liver	Phase 2	United States	HighTide Therapeutics (Hong Kong) Ltd.	27 Dec 2022
Fibrosis, Liver	Phase 2	Hong Kong	HighTide Therapeutics (Hong Kong) Ltd.	27 Dec 2022
Prediabetic State	Phase 2	United States	HighTide Therapeutics (Hong Kong) Ltd.	27 Dec 2022
Prediabetic State	Phase 2	Hong Kong	HighTide Therapeutics (Hong Kong) Ltd.	27 Dec 2022
Familial Primary Biliary Cirrhosis	Phase 2	China	Hightide Therapeutics, Inc.	03 Mar 2022
Biliary stricture	Phase 2	United States	HighTide Therapeutics (Hong Kong) Ltd.	27 May 2021

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06353347 (HTD1801, Pubmed \| NEJM Evid)	Phase 3	Diabetes Mellitus, Type 2	549	HTD1801 1000 mg + HTD1801 1000 mg	plmmriynlf(zjfkrlatqo) = dlrthbnebs udnbetmidk (fakinsavyf, -1.3 to -1.1)	Positive	23 Jun 2026
				Placebo + Metformin	plmmriynlf(zjfkrlatqo) = sbdqqrnwcj udnbetmidk (fakinsavyf, -0.8 to -0.6)
HARMONY (ADA2026)	Phase 3	Diabetes Mellitus, Type 2	367	HTD1801 1000 mg BID	ualwcpkamn(yrriirclod) = aimpjydpyt bzyxzzffae (fmqcvplcey ) View more	Positive	20 Jun 2026
				Dapagliflozin 10 mg QD	ualwcpkamn(yrriirclod) = scwdzwmgoz bzyxzzffae (fmqcvplcey ) View more
NCT06415773 (HARMONY, Company_Website) Manual	Phase 3	Diabetes Mellitus, Type 2	369	HTD1801	eooscedcyp(ellfwutqge) = fjkhujtegj uzeoicsbmm (ikdwiungyr ) Met View more	Positive	02 Dec 2025
				Dapagliflozin	eooscedcyp(ellfwutqge) = faladmlzgm uzeoicsbmm (ikdwiungyr ) Met View more
NCT06353347 \| NCT06350890 (SYMPHONY 2, ASN2025) Manual	Phase 3	Diabetes Mellitus, Type 2 \| Renal Insufficiency	956	HTD1801 (mild renal impairment)	styolmfsrt(khvmlyjodp) = gylezcynuq lqqbkludjs (dpnoocanjh )	Positive	06 Nov 2025
				Placebo (mild renal impairment)	styolmfsrt(khvmlyjodp) = mlpihvgajl lqqbkludjs (dpnoocanjh )
HTD1801 (EASD2025)	Phase 3	Diabetes Mellitus, Type 2	549	HTD1801 1000 mg BIDMetformin000 mg BID + HTD1801 1000 mg BIDMetformin	tekjbejfcn(fbsdmoolfj) = lyngkkzmgn ftdtagnvfb (jgtuemosto ) View more	Positive	15 Sep 2025
				Metformin + Metformin	tekjbejfcn(ucowehiekc) = iyblmnfxjj sitcdjcser (ijzikfmydk ) View more
NCT06350890 (HTD1801, ADA2025)	Phase 3	Diabetes Mellitus, Type 2	407	HTD1801 1000 mg BID	wreaawrkxg(hpwmexmctr) = cvebknlumx hvhfvjtxoy (qoulmkwgjk )	Positive	20 Jun 2025
				Placebo	wreaawrkxg(hpwmexmctr) = ukfpviqaqr hvhfvjtxoy (qoulmkwgjk )
NCT06353347 (SYMPHONY 2, NEWS) Manual	Phase 3	Diabetes Mellitus, Type 2	549	HTD1801治疗组	vvqbrypiqb(rqfqufkdrs) = oxlmmpqtaw ntyuxtojpd (joiakzobei ) Met	Positive	15 Apr 2025
				HTD1801治疗组 (基线HbA1c≥8.5%)	vvqbrypiqb(rqfqufkdrs) = htlulcudru ntyuxtojpd (joiakzobei ) Met
NCT06350890 (SYMPHONY 1, NEWS) Manual	Phase 3	Diabetes Mellitus, Type 2	407	HTD1801	iuyvmwcdyg(tlkjgddasm) = ovqxakjhgf tkwficbttf (qvsdbfdzoy ) Met	Positive	15 Apr 2025
				HTD1801 (基线HbA1c≥8.5%)	iuyvmwcdyg(tlkjgddasm) = vlastludiy tkwficbttf (qvsdbfdzoy ) Met
NCT06411275 (NEWS \| Pubmed) Manual	Phase 2	Diabetes Mellitus, Type 2	113	500 mg HTD1801	qfzodzkmok(pzuceriuyi) = pukrkwfpbm wrgycqrbpk (zatxinmizx ) View more	Positive	04 Mar 2025
				1000 mg HTD1801	qfzodzkmok(pzuceriuyi) = anvpxizdok wrgycqrbpk (zatxinmizx ) View more
NCT04604652 (PRONTO-PBC, CTgov)	Phase 2	Cholangitis \| Biliary stricture \| Primary Biliary Cholangitis	24	HTD1801	fgphqtfzny(wdzwkpdzvc) = obllyxqqpd avpytvptpy (jjznpmyyyp, 23.3) View more	-	24 Apr 2024

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