A Phase 1 Study of GZC8072 Tablets Following a Single Dose in Healthy Study Participants and Multiple Doses in Obese/Overweight Study Participants

NCT07784699 | Not Yet Recruiting Phase 1

• 1 other identifier: GZC8072-BWM-101
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in China. This study plans to include 2 parts, i.e., a single-dose study and a multiple-dose study: The single-dose study will be conducted in healthy adult participants to evaluate the safety, tolerability, and pharmacokinetic profile of single doses of GZC8072 Tablets; The multiple-dose study will be conducted in obese or overweight study participants to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profiles of multiple doses of GZC8072 Tablets.

Conditions

Healthy Subjects;Overweight or Obesity

Keywords

GZC8072 Tablets;Overweight or Obesity

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events and serious adverse events

  SAD:Baseline to Day36 MAD:Baseline to Day57

• mmunogenicity: including anti-drug antibodies and neutralizing antibodies to GZC8072.

  SAD:Baseline to Day36 MAD:Baseline to Day57

Secondary Outcomes (17)

• Cmax

  SAD:Baseline to Day36 MAD:Baseline to Day57

• AUC0-t

  SAD:Baseline to Day36 MAD:Baseline to Day57

• AUC0-inf

  SAD:Baseline to Day36 MAD:Baseline to Day57

• Tmax

  SAD:Baseline to Day36 MAD:Baseline to Day57

• λ

  SAD:Baseline to Day36 MAD:Baseline to Day57

Study Arms (2)

GZC8072 Tablets

EXPERIMENTAL

Each participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of GZC8072 Tablets

Drug: GZC8072 Tablets

Placebo

PLACEBO COMPARATOR

Each participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of matched placebo.

Drug: Placebo

Interventions

GZC8072 Tablets DRUG

Oral drug

GZC8072 Tablets

Placebo DRUG

Oral drug

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• SAD：
• Provide written informed consent, fully understand the purpose and stipulated procedures of this study, and be willing to participate.
• Male or female, aged 18-55 years (inclusive) at the time of signing the ICF.
• Body mass index (BMI) at screening is 19.0-28.0 kg/m² (inclusive); and weight is ≥ 54.0 kg for males and ≥ 50.0 kg for females.
• Participants must agree to take reliable contraceptive measures for themselves and their partners during the study and within 3 months after administration, and not donate sperm or eggs (egg cells, oocytes) for assisted reproductive purposes.
• MAD:
• Provide written informed consent, fully understand the purpose and stipulated procedures of this study, and be willing to participate.
• Male or female, aged 18-55 years (inclusive) at the time of signing the ICF.
• At screening, the body mass index (BMI) is 24 kg/m2 to 35 kg/m2 (inclusive).
• Participants must agree to take reliable contraceptive measures for themselves and their partners during the study and within 3 months after the last dose, and not donate sperm or eggs (egg cells, oocytes) for assisted reproductive purposes.

You may not qualify if:

• SAD:
• History of allergic diathesis, or allergic diseases such as bronchial asthma, urticaria, or eczema (except for mild seasonal allergies) prior to screening, or known or suspected allergy, intolerance, or hypersensitivity to GLP-1RA drugs, SNAC, C10 or other excipients of the investigational medicinal product (IMP) at screening.
• Participants with a previous or existing history of cardiovascular system, digestive system, respiratory system, urinary system, blood system, nervous system, psychiatric disorders, endocrine diseases (except obesity or overweight), malignant tumors and other diseases that are judged by the investigator to have an impact on the evaluation of the results of this study.
• Hemorrhage tendency (including but not limited to non-traumatic hemorrhage) within 6 months before screening, or presence of diseases with increased hemorrhage tendency that are clearly diagnosed.
• History of hypoglycemia (including symptomatic hypoglycemia) within 3 months prior to screening.
• History of acute or chronic pancreatitis, symptomatic gallbladder disease, pancreatic surgery or trauma before screening; high-risk cholelithiasis (such as sand-like stones, gallbladder and bile duct stones ≤ 5 mm in diameter) during screening; newly diagnosed cholecystitis at screening.
• Presence of reflux esophagitis at screening, functional dyspepsia, constipation, irritable bowel syndrome, intestinal obstruction, abnormal gastric emptying (e.g., pyloric obstruction), or active peptic ulcer.
• History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 prior to screening, or presence of suspected and/or diagnosed malignancy at screening, or history of malignancy prior to screening.
• Participants who have any clinically significant abnormalities in 12-lead ECG, vital signs (blood pressure, respiration, pulse and body temperature), physical examinations, imaging procedures or laboratory tests (hematology, urinalysis, blood biochemistry and coagulation) at screening or predose as judged by the investigator to be unsuitable for participation in this study, or whose laboratory test items at screening or predose meet any of the following criteria:
• eGFR \< 90 mL/min/1.73 m2 (eGFR should be estimated using the CKD-EPI formula);
• Abnormal fasting plasma glucose (FPG) (FPG ≥ 6.1 mmol/L, or \< 3.9 mmol/L);
• Hemoglobin A1c (HbA1c) ≥ 6.5%;
• Calcitonin ≥ 20 pg/mL;
• Those who are positive for four tests for infectious diseases.
• Major surgery within 6 months prior to screening, or scheduled surgery or hospitalization during the study.

Sponsors & Collaborators

• Gan & Lee Pharmaceuticals.: lead

Study Sites (1)

Beijing Shijitan Hospital

Beijing, China

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zhuoran Li

CONTACT

010-56456739; zhuoran.li@ganlee.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 25, 2026
• Study Start (Estimated): September 4, 2026
• Primary Completion (Estimated): August 18, 2027
• Study Completion (Estimated): August 18, 2027
• Last Updated: August 25, 2026

Record last verified: 2026-08

Locations

CN (1)