APL-18881 / Sunshine Lake Pharma, Apollo Therap - LARVOL DELTA

Efficacy of a GLP-1/FGF21 Dual Agonist for Treating PCOS (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Shanghai Zhongshan Hospital

New P2 trial • Polyendocrine Metabolic Ovarian Syndrome

RANDOMIZED, PLACEBO CONTROLLED PHASE 1B TRIAL OF APL-18881, A NOVEL FGF21 AND GLP-1 BISPECIFIC DUAL RECEPTOR AGONIST, EVALUATING MEASURES OF METABOLIC AND LIVER HEALTH IN PATIENTS WITH TYPE 2 DIABETES AFTER 5 WEEKS OF TREATMENT (AASLD 2025) - " HEC88473-DM-101 was a single-centre, randomized, double-blind, placebo-controlled Phase 1b trial to evaluate the safety, tolerability, PK, and PD of APL-18881. APL-18881 demonstrated robust dose-dependent improvement in measures of metabolic and liver health in a Phase 1b MAD trial in participants with T2D after 5 weeks of treatment. The effects observed on MRI-PDFF and liver stiffness support the potential of APL-18881 to be an effective therapeutic in SLD."

Clinical • P1 data • Diabetes • Hepatology • Metabolic Disorders • Type 2 Diabetes Mellitus • FGF21

Phase 2 Study of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=234 | Completed | Sponsor: Dongguan HEC Biopharmaceutical R&D Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Sep 2024 ➔ Apr 2025 | Trial primary completion date: Sep 2024 ➔ Feb 2025

Trial completion • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

First-in-Human Study on Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Escalating Doses of HEC88473, a Novel Dual GLP-1 and FGF21 Receptor Agonist in Healthy and Obese Chinese Subjects. (PubMed, BioDrugs) - P1 | "HEC88473 is well tolerated in healthy and obese subjects, and it shows glucose-lowering and lipid-lowering efficacies. The data support further clinical evaluations of HEC88473 for the treatment of metabolic diseases."

Journal • P1 data • PK/PD data • Gastroenterology • Gastrointestinal Disorder • Metabolic Disorders • Obesity • FGF21

Safety and efficacy of GLP-1/FGF21 dual agonist HEC88473 in MASLD and T2DM: a randomized, double-blind, placebo-controlled study. (PubMed, J Hepatol) - "Herein, we report the clinical safety and proof of concept data for the GLP-1/FGF21 dual agonist HEC88473. A 5-week treatment with HEC88473 was generally safe and well tolerated, with multiple positive effects observed, including reduced liver fat, and improved glycemic control, insulin resistance and lipid metabolism, together indicating comprehensive improvement in metabolic syndrome."

Clinical • Journal • Diabetes • Gastroenterology • Gastrointestinal Disorder • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Type 2 Diabetes Mellitus • FGF21

Phase 2 Study of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=225 | Recruiting | Sponsor: Dongguan HEC Biopharmaceutical R&D Co., Ltd.

New P2 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF A NOVEL GLP-1/FGF21 DUAL AGONIST HEC88473 IN TYPE 2 DIABETES PATIENTS WITH NONALCOHOLIC FATTY LIVER DISEASE: A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, PHASE 1b/2a MULTIPLEASCENDING-DOSE STUDY (AASLD 2023) - "To our knowledge, this study presents the first clinical safety and proof of concept data for the GLP-1/FGF21 dual agonist class. Five weeks treatment with HEC88473 was safe and well tolerated and associated with clinically meaningful reductions in LFC as well as HbA1c levels in T2MD patients combined with NAFLD."

Clinical • Late-breaking abstract • P1/2 data • PK/PD data • Addiction (Opioid and Alcohol) • Diabetes • Dyslipidemia • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Hepatology • Metabolic Disorders • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis • Obesity • Type 2 Diabetes Mellitus • FGF21

A Phase 1 Study of HEC88473 Injection in Healthy Subjects, Obese Subjects and T2DM Subjects (clinicaltrials.gov) - P1 | N=164 | Completed | Sponsor: Dongguan HEC Biopharmaceutical R&D Co., Ltd.

New P1 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

The Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of HEC88473 in Healthy Subjects (clinicaltrials.gov) - P1 | N=64 | Completed | Sponsor: Dongguan HEC Biopharmaceutical R&D Co., Ltd. | Recruiting ➔ Completed | N=100 ➔ 64 | Trial completion date: Dec 2022 ➔ Mar 2022 | Trial primary completion date: Dec 2022 ➔ Mar 2022

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Hepatology • Non-alcoholic Steatohepatitis