DA-302168S / Chengdu Di’ao - LARVOL DELTA

PANDA-1: A Study of DA-302168S in Participants With Overweight/Obesity (clinicaltrials.gov) - P3 | N=840 | Recruiting | Sponsor: Chendu DIAO Pharmaceutical Group CO., LTD. | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

A Study to Evaluate the Efficacy and Safety of DA-302168S Tablets in Subjects With Type 2 Diabetes (clinicaltrials.gov) - P2 | N=272 | Not yet recruiting | Sponsor: Chendu DIAO Pharmaceutical Group CO., LTD.

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

Efficacy and Safety of DA-302168S, a Novel Oral GLP-1 Receptor Agonist, in Chinese Adults with Overweight or Obesity: A Phase 2 Trial (ADA 2026) - "DA-302168S induced robust clinically meaningful weight loss with improved cardiometabolic risk factors (BP, waist circumference) and favorable safety profile, supporting its further development as oral weight management therapy."

Clinical • P2 data • Metabolic Disorders • Obesity

PANDA-1: A Study of DA-302168S in Participants With Overweight/Obesity (clinicaltrials.gov) - P3 | N=840 | Not yet recruiting | Sponsor: Chendu DIAO Pharmaceutical Group CO., LTD.

New P3 trial • Genetic Disorders • Obesity

DA168: A Study to Evaluate the Efficacy and Safety of DA-302168S Tablets in Overweight/Obese Subjects (clinicaltrials.gov) - P2 | N=250 | Completed | Sponsor: Chendu DIAO Pharmaceutical Group CO., LTD. | Active, not recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

Phase I study of the oral GLP-1 receptor agonist DA-302168S: Safety, pharmacokinetics, and pharmacodynamics in healthy and overweight/obese adults. (PubMed, Diabetes Obes Metab) - "DA-302168S demonstrates a favourable safety and PK profile, coupled with substantial, dose-dependent weight loss and metabolic benefits. These results strongly support its continued development as a promising once-daily oral therapy for obesity and type 2 diabetes."

Journal • P1 data • PK/PD data • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

DA168: A Study to Evaluate the Efficacy and Safety of DA-302168S Tablets in Overweight/Obese Subjects (clinicaltrials.gov) - P2 | N=240 | Active, not recruiting | Sponsor: Chendu DIAO Pharmaceutical Group CO., LTD. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

DA168: A Study to Evaluate the Efficacy and Safety of DA-302168S Tablets in Overweight/Obese Subjects (clinicaltrials.gov) - P2 | N=240 | Not yet recruiting | Sponsor: Chendu DIAO Pharmaceutical Group CO., LTD.

New P2 trial • Genetic Disorders • Obesity

Discovery and Evaluation of DA-302168S as an Efficacious Oral Small-Molecule Glucagon-Like Peptide-1 Receptor Agonist. (PubMed, J Med Chem) - "These findings suggest that compound 29 offers a promising therapeutic option for the management of T2D and obesity. Notably, it has successfully completed phase I clinical trials and is currently undergoing phase II clinical trials."

Journal • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

DA168: The Food Effect on Pharmacokinetics of DA-302168S (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Chendu DIAO Pharmaceutical Group CO., LTD. | Enrolling by invitation ➔ Completed

Trial completion • Genetic Disorders • Obesity

DA168: A Study Evulating DA-302168S Tablets in Overweight/Obese Subjects (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Chendu DIAO Pharmaceutical Group CO., LTD. | Not yet recruiting ➔ Completed | Trial completion date: Sep 2025 ➔ Jan 2025 | Trial primary completion date: Jun 2025 ➔ Jan 2025

Trial completion • Trial completion date • Trial primary completion date • Genetic Disorders • Obesity

DA168: Safety, Tolerability and Pharmacokinetic Characteristics Evaluation of DA-302168S Tablets (clinicaltrials.gov) - P1 | N=50 | Completed | Sponsor: Chendu DIAO Pharmaceutical Group CO., LTD. | Recruiting ➔ Completed | N=152 ➔ 50 | Trial completion date: Jun 2025 ➔ Dec 2024

Enrollment change • Trial completion • Trial completion date • Genetic Disorders • Obesity

Weight loss exceeded 7% in 28 days, Chengdu Di'ao oral GLP-1RA made its debut: China and the United States simultaneously promoted Phase II clinical trials [Google translation] (zhihu.com) - "Recently, Chengdu Diao Pharmaceutical Group Co., Ltd...announced that its independently developed oral small molecule GLP-1 receptor agonist DA-302168S has been approved by the US FDA to conduct Phase II clinical trials in overweight or obese people. At the same time, the clinical registration platform of the China Center for Drug Evaluation (CDE) announced on March 26, 2025 that the drug has started domestic Phase II clinical research. This study is led by Professor Ji Linong of Peking University People's Hospital and is planned to be conducted in 20 hospitals in China, mainly for the treatment of overweight and obesity."

New P2 trial • Trial status • Obesity

A Phase Ic Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Administrations of DA-302168S Tablets in Overweight/Obese Subjects (ChiCTR) - P1 | N=60 | Not yet recruiting | Sponsor: The Second Affiliated Hospital of Anhui Medical University; The Second Affiliated Hospital of Anhui Medical University

New P1 trial • Obesity

DA168: A Study Evulating DA-302168S Tablets in Overweight/Obese Subjects (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Chendu DIAO Pharmaceutical Group CO., LTD.

New P1 trial • Genetic Disorders • Obesity

DA168: The Food Effect on Pharmacokinetics of DA-302168S (clinicaltrials.gov) - P1 | N=16 | Enrolling by invitation | Sponsor: Chendu DIAO Pharmaceutical Group CO., LTD.

New P1 trial • Genetic Disorders • Obesity

DA168: Safety, Tolerability and Pharmacokinetic Characteristics Evaluation of DA-302168S Tablets (clinicaltrials.gov) - P1 | N=152 | Recruiting | Sponsor: Chendu DIAO Pharmaceutical Group CO., LTD.

New P1 trial • Genetic Disorders • Obesity