A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Treatment With DD01 for 48 Weeks in Overweight/Obese Subjects With MASLD/MASH

This is a Phase 2 Study to evaluate the effect of DD01 treatment in overweight/obese patients with metabolic dysfunction-associated steatotic liver disease (MASLD)/metabolic dysfunction-associated steatohepatitis (MASH).

Start Date01 Jun 2024

Sponsor / Collaborator

Neuraly, Inc.Startup

NCT04812262 / CompletedPhase 1

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DD01 in Overweight/Obese Subjects With T2DM and NAFLD

This is a Phase 1, first in human (FiH), randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study to investigate the safety, tolerability, PK and PD of DD01 administered by subcutaneous (SC) injection in overweight/obese subjects with type 2 diabetes (T2DM) and nonalcoholic fatty liver disease (NAFLD).
The study will be conducted in 2 Parts (Part A and B), with up to 8 cohorts included in each part (Part A; Cohorts A1 to A8 and Part B; Cohorts B2 to B8).

Start Date24 Feb 2021

Sponsor / Collaborator

Neuraly, Inc.Startup

100 Clinical Results associated with DD-01

100 Translational Medicine associated with DD-01

100 Patents (Medical) associated with DD-01

Literatures (Medical) associated with DD-01

11 Apr 2023·Analytical chemistry

Fluorous Liquids for Magnetic Resonance-Based Thermometry with Enhanced Responsiveness and Environmental Degradation.

Article

Author: Mundhenke, Thomas F. ; Arnold, William A. ; Li, Jiaqian ; Smith, Thomas G. ; Pomerantz, William C. K.

Accurate temperature measurement via magnetic resonance is valuable for both in vitro and in vivo analysis of local tissue for evaluating disease pathology and medical interventions. ¹H MRI-based thermometry is used clinically but is susceptible to error from magnetic field drift and low sensitivity in fatty tissue and requires a reference for absolute temperature determination. As an alternative, perfluorotributylamine (PFTBA), a perfluorocarbon liquid for ¹⁹F MRI thermometry, is based on chemical shift responsiveness and approaches the sensitivity of ¹H MRI thermometry agents; however, environmental persistence, greenhouse gas concerns, and multiple resonances which can lead to MRI artifacts indicate a need for alternative sensors. Using a ¹⁹F NMR-based structure-property study of synthetic organofluorine molecules, this research develops new organofluorine liquids with improved temperature responsiveness, high signal, and reduced nonmagnetically equivalent fluorine resonances. Environmental degradation analysis using reverse-phase HPLC and quantitative ¹⁹F NMR demonstrates a rapid degradation profile mediated via the aryl fluorine core of temperature sensors. Our findings show that our lead liquid temperature sensor, DD-1, can be made in high yield in a single step and possesses an improved responsiveness over our prior work and an 83% increase in aqueous thermal responsiveness over PFTBA. Degradation studies indicate robust degradation with half-lives of less than two hours under photolysis conditions for the parent compound and formation of other fluorinated products. The improved performance of DD-1 and its susceptibility to environmental degradation highlight a new lead fluorous liquid for thermometry applications.

01 Jan 2008·European journal of pharmacologyQ3 · MEDICINE

Tolterodine does not affect memory assessed by passive-avoidance response test in mice

Q3 · MEDICINE

Article

Author: Richard H. Alper ; Gregory L. Finch ; Donald Newgreen ; Brian Bush ; Gregg D. Cappon

Antimuscarinics are first-line pharmacotherapy for the treatment of overactive bladder. However, because central nervous system cholinergic neurotransmission is involved in cognition, and the central nervous system-permeable antimuscarinics scopolamine and oxybutynin affect memory, cognitive impairment has been noted as a possible side effect of these drugs. We evaluated the effect of tolterodine, an antimuscarinic for overactive bladder, in a mouse passive-avoidance model of memory. Mice were chosen because like humans, mice but not rats, form the pharmacologically active 5-hydroxymethyl metabolite of tolterodine, DD01. In the passive-avoidance test, tolterodine at 1 or 3 mg/kg had no effect on memory; the latency to cross and percentage of animals crossing were comparable to controls. In contrast, scopolamine induced a memory deficit; the latency to cross was decreased, and the number of animals crossing was increased. Therefore, at a dose exceeding therapeutic exposure by six-fold, tolterodine had no effect on memory in the mouse passive-avoidance model, indicating that tolterodine does not disrupt cognitive function in this testing paradigm.

01 Jan 2006·Brazilian dental journal

Effect of commercially available and experimental potassium oxalate-based dentin desensitizing agents in dentin permeability: influence of time and filtration system

Article

Author: Santiago, Sérgio Lima ; Martineli, Ana Christina Bonato Figueiredo ; Pereira, José Carlos

This study evaluated the influence of time after application of oxalate solutions in reducing dentin hydraulic conductance. Fifty dentin discs were obtained from extracted human third molars and assigned to 5 groups (n=10), according to the desensitizing agent used: Group I: OxaGel; Group II: experimental agent DD-1: Group III: experimental agent DD-2. In Groups IV and V, a placebo gel and deionized water were used as control, respectively. The agents were applied for 3 min, washed out and the hydraulic conductance was measured immediately and at 5-, 15- and 30-min intervals, and after acid etching. Data were analyzed statistically by two-way ANOVA and Duncan's test at 5% significance level. Groups I, II and III did not differ significantly from each other in any of the time intervals (p>0.05). Likewise, Groups IV and V were statistically similar to each other (p>0.05). The active agents reduced significantly dentin permeability in comparison to control groups (p<0.05). Dentin permeability measured in vitro decreased significantly with time regardless of the agent applied (either active or control agents). The results of Group V, in which no dentin desensitizing agent was employed, indicates that the assessment of dentin permeability by this method must be interpreted with caution.

News (Medical) associated with DD-01

02 Apr 2024

·www.biospace.com

D&D Pharmatech Granted Fast Track Designation from US FDA for DD01 for the Treatment of NASH/MASH

The Fast Track designation accelerates DD01’s path to U.S. FDA submission for the treatment of adults with MASLD/MASH GYEONGGI-DO, South Korea & GAITHERSBURG, Md.--(BUSINESS WIRE)-- D&D Pharmatech, Inc. (D&D), a clinical-stage biotechnology company focused on the development of disease-modifying drugs, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of DD01 for the treatment of adults with non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction-associated steatohepatitis (MASH). FDA Fast Track designation is intended to bring promising drugs to patients sooner by facilitating the development and expediting the review of drugs that fulfill unmet needs in serious diseases. The FDA based its decision on data from Phase 1, a randomized, double-blind, placebo-controlled study assessing the safety and efficacy of DD01 in overweight/obese subjects with type 2 diabetes (T2D) and metabolic dysfunction-associated fatty liver disease (MAFLD). In that study, DD01 treatment was well tolerated and reduced hepatic steatosis by >50% in only 4 weeks with up to 100% of subjects achieving ≥30% liver fat reduction by MRI-PDFF. In animal models, DD01 treatment reduced hepatic steatosis, lobular inflammation, ballooning, and signs of fibrosis, all key diagnostic criteria MASH. Weight loss and improved glycemic control were also observed. For many patients, co-occurring type 2 diabetes and obesity are underlying factors. Preclinical and clinical results suggest DD01 treatment may be beneficial in the treatment of fatty liver disease and can improve glycemic control and weight loss in subjects who are overweight or have type 2 diabetes. “We are pleased with the FDA’s decision to grant Fast Track designation for DD01 and look forward to initiating a Phase 2 study in biopsy-confirmed MASH patients,” said Seulki Lee, Ph.D., CEO of D&D. “MASH has a significant unmet need. Multiple clinical trials have recently proven that efficiently reducing excessive liver fat content leads to ameliorating MASH and liver scarring. DD01 provides rapid reductions in liver fat and beneficial effects on glucose control; thus, we anticipate further studying DD01 in biopsy-confirmed MASH patients after prolonged treatment in an upcoming Phase 2.” About DD01 DD01 is a proprietary, once-weekly dual agonist of GLP-1 (glucagon-like peptide-1) and glucagon receptors with a half-life of 7-8 days in obese/overweight patients with T2D and MAFLD. A key differentiator for DD01 lies in its dual pathway mechanism of action. Unlike other single and dual agonists, which act only through the incretin pathway, DD01 augments the benefits of incretin therapy acting through the glucagon receptor and enhancing liver lipolysis, leading to rapid effectiveness and the potential to treat the liver first. DD01 treatment results in rapid and clinically significant reductions in liver fat in only 4 weeks of treatment from MAFLD patients. In preclinical studies, DD01 caused significant weight loss, reduced liver fat and fibrosis, and improved glucose tolerance in various preclinical models of obesity, diabetes, and fatty liver, including non-human primates. About D&D Pharmatech D&D Pharmatech is a clinical-stage global biotech company that funds the development of revolutionary medicines through disease-specific subsidiary companies founded and guided by top-tier medical research faculty. This corporate structure creates a unique opportunity to accelerate the translation of cutting-edge research into lifesaving therapeutic products for patients. The company’s product pipeline focuses on metabolic diseases, including obesity, MASH and fibrosis, and neurodegenerative diseases. For more information, please visit . Neuraly Inc. is a wholly owned US subsidiary of D&D Pharmatech. View source version on businesswire.com: Contacts Neuraly Inc. Ben Gibson 240-937-5876 bgibson@neuralymed.com Source: D&D Pharmatech, Inc. View this news release online at:

Fast TrackPhase 1Phase 2Clinical Result

02 May 2023

·pipelinereview.com

D&D Pharmatech Announces Rapid, Clinically Significant Reductions in Liver Fat Achieved in Four Weeks Treating NAFLD Patients with DD01, a Novel Long-Acting GLP-1/Glucagon Receptor Agonist

- Study results demonstrate DD01 was safe and well-tolerated at doses highly effective in reducing fatty liver. - Following only 4 weeks of treatment, all subjects in high dose group achieved at least a 40% reduction in liver fat with a mean reduction of >50% measured by MRI-PDFF (p < 0.0001 v.s. placebo group). - DD01 provides a unique balance of GLP-1/Glucagon activity that achieves rapid reductions in liver fat even without the weight loss observed at higher doses, thus offering the potential to treat fatty liver disease independent of the long-term treatment needed to achieve the same effect with an incretin alone. GYEONGGI-DO, South Korea & GAITHERSBURG, MD, USA I May 02, 2023 I D&D Pharmatech, Inc. (D&D), a clinical-stage biotechnology company focused on the development of disease-modifying drugs, today announced positive topline results from its Phase 1 clinical trial of DD01 in overweight/obese patients with type 2 diabetes (T2D) and non-alcoholic fatty liver disease (NAFLD). DD01 is a long-lasting, dual GLP-1/glucagon receptor agonist designed to rapidly resolve hepatic steatosis, improve glycemic control, and reduce body weight in fatty liver disease with and without co-occurring T2D and obesity. This trial was a randomized, double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) studies performed at four clinical sites in the U.S. Eligible participants included T2D who are overweight/obese for SAD study and obese with T2D and NAFLD for MAD study with a minimum body mass index (BMI) of 30 kg/m2 and hepatic fat contents of ≥10% by MRI-PDFF. A total hundred-seven (107) subjects were enrolled, and fifty (50) subjects in the MAD portion were assigned to receive subcutaneous doses of DD01 at up to 80 mg or placebo once weekly for four weeks without dose titration. The trial was designed to assess the safety, pharmacokinetics, and pharmacodynamic effects of DD01. DD01 was generally safe and well tolerated with gastrointestinal adverse events like those reported for selective GLP-1 receptor agonists. Following only four (4) weeks of once-weekly treatment, up to 100% of patients achieved >30% liver fat reduction by MRI-PDFF. A mean relative reduction in liver fat content of >50% was observed in a pooled analysis of the two high doses of DD01, whereas the change from baseline in placebo-treated subjects was <5%. Rapid improvements in steatosis were observed at well-tolerated doses and accompanied by increased insulin, decreased HbA1c, and weight loss at higher doses. In obese, diabetic subjects with NAFLD, the dual-pathway effect of DD01, acting through both the GLP-1 and glucagon receptor, was apparent and beneficial to these commonly co-morbid conditions. Presentation of clinical data showing the effects of DD01 and preclinical data illustrating highlights of the underlying mechanism of action is planned for upcoming conferences in 2023. “We are thrilled to receive the positive topline results from this initial trial that show DD01 has strong potential to rapidly reduce fatty liver independent of the longer-term goal of weight loss recommended for some patients. Due to its rapid action and beneficial effects on glucose control, DD01 may provide an effective adjunct to diet and exercise in these patients, uncoupling the need for weight loss to precede improvements in liver health,” said Adam Bell, Ph.D., VP of Translational Medicine and Regulatory Affairs. “Direct targeting of fatty liver has proven beneficial in NASH patients. A ≥30% reduction in liver fat is associated with a clinically significant improvement in NASH scores. In NAFLD, DD01 achieved and exceeded this level in only 4 weeks,” added Seulki Lee, Ph.D., President, and Chief Executive Officer of D&D Pharmatech. “With these positive results, we look forward to conducting a Phase 2 study to further validate the utility of DD01 in the treatment of NAFLD and NASH both with and without co-occurring obesity and diabetes.” More information about the study is available at www.clinicaltrials.gov under the identifier NCT04812262. Clinical Implications At present, there are no treatments for nonalcoholic fatty liver disease. While both pre-diabetic and diabetic patients routinely present with fatty liver disease, doctors typically recommend weight loss, which can be effective but is slow and, for many patients, proves challenging. DD01 treatment results in rapid and clinically significant reductions in liver fat in only 4 weeks of treatment. One could easily envision using DD01 as an adjunct to diet and exercise to improve liver health rapidly. Patients may achieve rapid reductions in liver fat while benefiting over the long term from improved glycemic control and weight loss. About DD01 DD01 is a proprietary, long-acting dual agonist of GLP-1 and glucagon receptors with a half-life of 7-8 days in obese/overweight patients with T2D and NAFLD. A key differentiator for DD01 lies in its dual pathway mechanism of action. Unlike other single and dual agonists, which act only through the incretin pathway, DD01 augments the benefits of incretin therapy acting through the glucagon receptor and enhancing liver lipolysis, leading to rapid effectiveness and the potential to treat the liver first. Treatment with DD01 caused significant weight loss, reduced liver fat, and improved glucose tolerance in various preclinical models of obesity, diabetes, and fatty liver, including non-human primates. About D&D Pharmatech D&D Pharmatech is a clinical-stage global biotech company that funds the development of revolutionary medicines through disease-specific subsidiary companies founded and guided by top-tier medical research faculty. This corporate structure creates a unique opportunity to accelerate the translation of cutting-edge research into lifesaving therapeutic products for patients. The company’s product pipeline focuses on various indications, including neurodegenerative, fibrotic, and metabolic diseases. For more information, please visit http://www.ddpharmatech.com/ . SOURCE: D&D Pharmatech

Clinical ResultPhase 2Phase 1

20 Dec 2022

·www.prnewswire.com

DelveInsight Estimates a Promising Picture of Obesity Pipeline Space Landscape as Key 100+ Pharma Companies Working in the Space

The prevalence of obesity has been rising since the past few years, which prompts the growing demand for treatment options. The increasing prevalence of Obesity and the growing research and development activities to develop novel therapies to treat obesity drive the market. The Companies developing the potential therapies in the last stage of development include Novo Nordisk, Eli Lilly and Company, Saniona, and several others. LAS VEGAS, Dec. 20, 2022 /PRNewswire/ -- DelveInsight's ' Obesity Pipeline Insight – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline obesity therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the obesity pipeline domain. Key Takeaways from the Obesity Pipeline Report DelveInsight's obesity pipeline report depicts a robust space with 100+ active players working to develop 130+ pipeline therapies for obesity treatment. Key obesity companies such as 180 Life Sciences, 9 meters, Aardvark Therapeutics, Adocia, Agentix, AgeX Therapeutics, Altimmune, Amgen, Antag Therapeutics, Aphaia Pharma, Aptorum Group, AstraZeneca, Bukwang Pharmaceutical, Caliway Biopharmaceutics Co Ltd, Can Fite Biopharma, Carmot Therapeutics, Inc., Cellivery Therapeutics Inc, CinFina Pharma, Clayton Biotech, Click Therapeutics, Corbus Pharma, DiscoveryBiomed Inc, Dong-A ST, Dongkook Pharmaceuticals, Eccogene, Elevian, Eli Lilly and Company, Empros Pharma, Enterin Inc., EraCal Therapeutics AG, ERX Pharmaceuticals, ERX Pharmaceuticals, Eternygen GmbH, Eurofarma, Gannex Pharma, Glaceum, Gmax Biopharm, GPER G-1 Development Group, LLC, Gubra Therapeutics, Hanmi Pharmaceutical, Hanmi Pharmaceuticals, Innovent Biologics, Jenrin Discovery, Jiangsu Hansoh Pharmaceutical, Kallyope, Kintai Therapeutics, Kriya Therapeutics, LG Life Sciences, Lipidio Pharmaceuticals, MakScientific, Nano Precision Medical, NeonMind Biosciences, Novartis, Novo Nordisk, NuSirt Biopharma, Otsuka Pharmaceutical Factory Inc, Pfizer, Raziel Therapeutics, Reata Pharmaceuticals, Regeneron Pharmaceuticals, Reviva Pharmaceuticals, Rivus Pharmaceuticals, Shionogi, SHIONOGI & Co., Ltd., Sigrid Therapeutics, SJT Molecular Research SL, Structure Therapeutics, Sun Pharmaceutical Industries, Techfields Pharma, Terns Pharmaceuticals, Tonix Pharmaceuticals, UGISense AG, Versanis Bio, Viking Therapeutics, YSOPIA Bioscience, Yuhan, Zealand Pharma, and others are evaluating new drugs for obesity to improve the treatment landscape. Promising obesity pipeline therapies in various stages of development include Semaglutide oral, Tirzepatide, Sibutramine/Topiramate, NNC0174-0833, Tesomet, SHR-20004, RZL-012, CT-868, PF-06882961, EMP-16, S-237648, LY3502970, ARD-101, NNC0165-1875, XW003, IBI362, TG103, Cotadutide, MBL949, PF-07081532, APHD-012, LY 3437943, HSG4112, Leucine/sildenafil, BI 456906, Pemvidutide, LY3841136, HM15136, GMA106, DD01, ZP8396, K833, NNC0480-0389, LB54640, CT-181, CB4211, CT-388, CIN-109, ERX-1000, DWP306001, SCO-094, S-309309, NO-13065, GDD3898, XW004, SCO-267, ASC41, AMG 133, LY3541105, AMG-786, HU6, BMS-963272, BI 1820237, Xla 1, Dapiglutide, PB-119, PB-718, AGTX-2004, ECC5004, Thermostem, XW017, HM 14320, TNX-2900, CF-102, XW 010, LR19020, LR19056, YH34160, NM-136, CIN 110, CIN 209, CIN 210, RSVI-301, PramExe, BC GlueExe, BC Pram GlueExe, AGEX BAT1, CLS-1, CRB-913, Tespria, AM 6545, LP-003, KT A522, JD5037, SJT4a, GL0034, TF0103, TERN-601, NEO-001, KTX 0200, ENT-03, Bimagrumab, VK2735, HUM-234, NPM 139, YHC2129, YHC2134, YHC1140, GSBR-2nd Gen, GSBR-3rd Gen, and others. In December 2022, Amgen announced new Phase I data from AMG 133. This first-in-human study was designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of AMG 133 in people with obesity and without diabetes (NCT04478708). The MAD cohorts showed mean percent changes in body weight (BW), ranging from -7.2% at the lowest dose (140mg Q4W), to -14.5% at the highest dose (420mg Q4W) by day 85. A substantial degree of weight loss was maintained beyond the treatment period, which will be shared as part of the oral presentation. Most treatment-emergent adverse events (TEAEs) were mild and transient. The majority of the TEAEs were GI-related, with the most common being nausea and vomiting, most events resolved within 48 hours. In December 2022, Poolbeg Pharma, a clinical-stage infectious disease company, acquired the exclusive license from InsuCaps to use its proprietary microencapsulation and nanoencapsulation oral delivery technologies in metabolic syndrome-related diseases, including obesity, pre-diabetes, and diabetes. In November 2022, Rhythm Pharmaceuticals, Inc. announced that Great Britain's Medicines & Healthcare products Regulatory Agency (MHRA) has expanded the marketing authorization for IMCIVREE® (setmelanotide) to include the treatment of obesity and control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS) in adult and pediatric patients 6 years of age and older. In November 2022, Reviva Pharmaceuticals Holdings, Inc. announced the issuance of a patent covering the composition of matter for RP1208 in Canada, adding to its existing protection in key markets around the world. The Canadian patent covers the compositions of novel phenylcycloalkylmethylamine derivatives and the use of the compositions for the treatment of obesity, related co-morbid conditions, and depression and related co-morbid conditions. In October 2022, Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track designation for the investigation of tirzepatide for the treatment of adults with obesity or overweight with weight-related comorbidities. In September 2022, Rivus Pharmaceuticals Inc. announced the completion of a USD 132 million Series B financing led by RA Capital Management with participation from Bain Capital Life Sciences, BB Biotech AG, and existing investors Longitude Capital, Medicxi, and RxCapital. This financing will further support the clinical advancement of lead candidate HU6, a first-in-class Controlled Metabolic Accelerator (CMA) designed to treat cardio-metabolic disease by addressing obesity, a primary driver of disease. In June 2022, LG Chem's new drug for treating genetic obesity received additional ODD (Orphan Drug Designation) from the US FDA. LG Chem announced on the 16th that the FDA recently granted ODD to ' LB54640' for the treatment of 'POMC (Proopiomelanocortin) deficiency.' In April 2022, Saniona announced that it paused the Phase IIb clinical trials testing Tesomet for people with Prader–Willi syndrome (PWS) and hypothalamic obesity (HO). The decision "is not related to the safety or efficacy of Tesomet and is entirely due to funding limitations. The company also announced a reprioritization and restructuring effort to immediately reduce operating expenses while maximizing cash resources. Request a sample and discover the recent advances in obesity drug treatment @ Obesity Pipeline Report The obesity pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage obesity drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the obesity clinical trial landscape. Obesity Overview Obesity is a chronic disease that causes abnormal or excessive fat accumulation or adipose tissue in the body, posing a health risk. It is caused by an imbalance between calories consumed and calories burned. The factors responsible for the causes of obesity include heredity, a sedentary lifestyle, excessive fat, sugar consumption (energy-dense meals), certain medications, and endocrine issues. Changes in the environment or society, as well as in behavior and culture, all directly impact. Obesity symptoms go beyond an increase in body fat. It can cause skin issues, shortness of breath, sleeping difficulties, and other symptoms. Some obesity symptoms have even been linked to an increased risk of developing certain diseases and disorders. In some cases, these can be life-threatening or even fatal. Find out more about drugs for obesity @ FDA-approved Obesity Drugs A snapshot of the Obesity Pipeline Drugs mentioned in the report: Learn more about the emerging obesity pipeline therapies @ Obesity Clinical Trials Obesity Therapeutics Assessment The obesity pipeline report proffers an integral view of obesity emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Obesity Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Parenteral, Intravenous, Subcutaneous, Topical Therapeutics Assessment By Molecule Type: Monoclonal Antibody, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: Glucagon like peptide 1 receptor agonists, Gastric inhibitory polypeptide receptor agonists, Beta 1 adrenergic receptor antagonists, Biogenic monoamine uptake inhibitors, Lipolysis modulators, Alpha-glucosidase inhibitors, Amylase inhibitors, Lipase inhibitors, Glucagon like peptide 1 receptor agonists, Glucagon receptor agonists, Islet amyloid polypeptide replacements Key Obesity Companies: 180 Life Sciences, 9 meters, Aardvark Therapeutics, Adocia, Agentix, AgeX Therapeutics, Altimmune, Amgen, Antag Therapeutics, Aphaia Pharma, Aptorum Group, AstraZeneca, Bukwang Pharmaceutical, Caliway Biopharmaceutics Co Ltd, Can Fite Biopharma, Carmot Therapeutics, Inc., Cellivery Therapeutics Inc, CinFina Pharma, Clayton Biotech, Click Therapeutics, Corbus Pharma, DiscoveryBiomed Inc, Dong-A ST, Dongkook Pharmaceuticals, Eccogene, Elevian, Eli Lilly and Company, Empros Pharma, Enterin Inc., EraCal Therapeutics AG, ERX Pharmaceuticals, ERX Pharmaceuticals, Eternygen GmbH, Eurofarma, Gannex Pharma, Glaceum, Gmax Biopharm, GPER G-1 Development Group, LLC, Gubra Therapeutics, Hanmi Pharmaceutical, Hanmi Pharmaceuticals, Innovent Biologics, Jenrin Discovery, Jiangsu Hansoh Pharmaceutical, Kallyope, Kintai Therapeutics, Kriya Therapeutics, LG Life Sciences, Lipidio Pharmaceuticals, MakScientific, Nano Precision Medical, NeonMind Biosciences, Novartis, Novo Nordisk, NuSirt Biopharma, Otsuka Pharmaceutical Factory Inc, Pfizer, Raziel Therapeutics, Reata Pharmaceuticals, Regeneron Pharmaceuticals, Reviva Pharmaceuticals, Rivus Pharmaceuticals, Shionogi, SHIONOGI & Co., Ltd., Sigrid Therapeutics, SJT Molecular Research SL, Structure Therapeutics, Sun Pharmaceutical Industries, Techfields Pharma, Terns Pharmaceuticals, Tonix Pharmaceuticals, UGISense AG, Versanis Bio, Viking Therapeutics, YSOPIA Bioscience, Yuhan, Zealand Pharma, and others. Key Obesity Pipeline Therapies: Semaglutide oral, Tirzepatide, Sibutramine/Topiramate, NNC0174-0833, Tesomet, SHR-20004, RZL-012, CT-868, PF-06882961, EMP-16, S-237648, LY3502970, ARD-101, NNC0165-1875, XW003, IBI362, TG103, Cotadutide, MBL949, PF-07081532, APHD-012, LY 3437943, HSG4112, Leucine/sildenafil, BI 456906, Pemvidutide, LY3841136, HM15136, GMA106, DD01, ZP8396, K833, NNC0480-0389, LB54640, CT-181, CB4211, CT-388, CIN-109, ERX-1000, DWP306001, SCO-094, S-309309, NO-13065, GDD3898, XW004, SCO-267, ASC41, AMG 133, LY3541105, AMG-786, HU6, BMS-963272, BI 1820237, Xla 1, Dapiglutide, PB-119, PB-718, AGTX-2004, ECC5004, Thermostem, XW017, HM 14320, TNX-2900, CF-102, XW 010, LR19020, LR19056, YH34160, NM-136, CIN 110, CIN 209, CIN 210, RSVI-301, PramExe, BC GlueExe, BC Pram GlueExe, AGEX BAT1, CLS-1, CRB-913, Tespria, AM 6545, LP-003, KT A522, JD5037, SJT4a, GL0034, TF0103, TERN-601, NEO-001, KTX 0200, ENT-03, Bimagrumab, VK2735, HUM-234, NPM 139, YHC2129, YHC2134, YHC1140, GSBR-2nd Gen, GSBR-3rd Gen, and others. Dive deep into rich insights for new drug for obesity treatment; visit @ Obesity Medications Table of Contents For further information on the obesity pipeline therapeutics, reach out @ Obesity Drug Treatment Related Reports Obesity Epidemiology Forecast Obesity Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the obesity epidemiology trends. Obesity Market Obesity Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key hypothalamic obesity companies, including Saniona, YSOPIA Bioscience, Innovent Biologics, Glaceum, Shionogi, Aardvark Therapeutics, among others. Hypothalamic Obesity Market Hypothalamic Obesity Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key hypothalamic obesity companies, including Altimmune, Saniona, YSOPIA Bioscience, Innovent Biologics, among others. Hypothalamic Obesity Pipeline Hypothalamic Obesity Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products and the key hypothalamic obesity companies, including Altimmune, Saniona, YSOPIA Bioscience, Innovent Biologics, among others. HET Obesity/POMC Deficiency Obesity Pipeline HET Obesity/POMC Deficiency Obesity Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products and the key HET obesity/POMC deficiency obesity companies, including Novo Nordisk, Eli Lilly, and Company, MedImmune, Boehringer Ingelheim, Raziel Therapeutics, among others. HET Obesity/POMC Deficiency Obesity Market HET Obesity/POMC Deficiency Obesity Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key HET obesity/POMC deficiency obesity companies, including Novo Nordisk, Eli Lilly, and Company, MedImmune, Boehringer Ingelheim, Raziel Therapeutics, among others. Other Trending Reports Goitre Market | Thymus Cancer Market | US Healthcare Outlook Report | Venous Stenosis Market | Negative Pressure Wound Therapy Systems Market | Metrorrhagia Market | Dysfunctional Uterine Bleeding Market | Hypereosinophilic Syndrome Market | Age-related Vision Dysfunction Market | Dental Lasers Market | CRISPR Therapies Pipeline Insight | Cell And Gene Therapy For Multiple Myeloma Market | Drug Hypersensitivity Market | Dysthymia Market | Persistent Depressive Disorder Market | Cancer Vaccines Market | Weight Loss/Weight Management (Obesity) Market | Food Allergy Market | Obsessive-Compulsive Disorder Market | Tumor Ablation Market | Physiotherapy Equipment Market | CAR-T Pipeline Insight | Anti-hypertension Market | Radiofrequency Ablation Devices Market | Global Messenger RNA (mRNA)-based Vaccines and Therapeutics Market | Gastro Intestinal Bleeding Market | Trastuzumab Biosimilars Insight | Varicose Veins Market | Germ Cell Tumor Market | Intracardiac Echocardiography Devices Market | India Healthcare Outlook Report | Crows Feet Market Insight | Seborrhoeic Dermatitis Market | Injectable Drug Delivery Devices Market | Structural Heart Devices Market | Substance (Drug) Abuse Market Related Healthcare Blogs Obesity: A Global Concern Weight Loss and Obesity Market Obesity Treatment Market Related Healthcare Services Healthcare Business Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Phase 1Orphan DrugFast TrackPhase 2License out/in

100 Deals associated with DD-01

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nonalcoholic Steatohepatitis	Phase 2	US	Neuraly, Inc.Startup	01 Jun 2024
Obesity	Phase 2	US	Neuraly, Inc.Startup	01 Jun 2024
Diabetes Mellitus, Type 2	Phase 1	US	Neuraly, Inc.Startup	24 Feb 2021
Diabetes Mellitus, Type 2	Phase 1	PR	Neuraly, Inc.Startup	24 Feb 2021
Metabolic dysfunction-associated steatotic liver disease	Phase 1	PR	Neuraly, Inc.Startup	24 Feb 2021

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


DD01 (ADA2023)	Not Applicable	Metabolic dysfunction-associated steatotic liver disease	-	DD01	wmpwinbryz(xnxdftiedr) = tatteycmuq bcrjfptzqr (zjoaqgpuhy )	Positive	20 Jun 2023
				Placebo	wmpwinbryz(xnxdftiedr) = bfooncjmdw bcrjfptzqr (zjoaqgpuhy )
DD01 (EASD2019)	Not Applicable	Obesity GLP-1R \| GCGR	-	DD01 (20 nmol/kg)	dtpouxttrj(zqztekmfji) = ocqbtjtuul jzgftipmna (pwzyvygcsl )	Positive	20 Sep 2019
				DD01 (40 nmol/kg)	dtpouxttrj(zqztekmfji) = ghfokpzocw jzgftipmna (pwzyvygcsl )

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