A Study of HS-20094 in Overweight or Obese Participants

NCT07057674 | Recruiting Phase 1

• 1 other identifier: HS-20094-106
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, open-label, parallel clinical study to evaluate the bioequivalence of the HS-20094 MDV pen and AI pen in overweight or obese subjects.

Conditions

Overweight or Obesity

Outcome Measures

Primary Outcomes (2)

• To evaluate the bioequivalence of HS-20094 MDV pen and AI pen following multiple doses at 15 mg.

  PK parameters of HS-20094 following multiple doses at 15 mg administered via HS-20094 MDV pen and AI pen: AUC0-168h.

  From Day 1 to Day 169

• To evaluate the bioequivalence of HS-20094 MDV pen and AI pen following multiple doses at 15 mg.

  PK parameters of HS-20094 following multiple doses at 15 mg administered via HS-20094 MDV pen and AI pen: Cmax

  From Day 1 to Day 169

Secondary Outcomes (9)

• To evaluate the bioequivalence of HS-20094 MDV pen and AI pen following multiple doses at 10 mg

  From Day 1 to Day 169

• To evaluate the bioequivalence of HS-20094 MDV pen and AI pen following multiple doses at 10 mg

  From Day 1 to Day 169

• To evaluate the safety following administration via the HS-20094 MDV pen and AI pen

  From Day 1 to Day 204

• Number of participants with Vital signs

  From Day 1 to Day 204

• To evaluate the safety following administration via the HS-20094 MDV pen and AI pen

  From Day 1 to Day 204

Study Arms (2)

T1 group

EXPERIMENTAL

HS-20094 AI pen administered subcutaneously (SC) once a week.

Drug: HS-20094 AI pen;

T2 group

EXPERIMENTAL

HS-20094 MDV pen administered subcutaneously (SC) once a week.

Drug: HS-20094 MDV pen

Interventions

HS-20094 AI pen; DRUG

Arm 1: Administered SC The dose is escalated every 4 weeks until the target dose of 15 mg is reached. The dose escalation scheme is as follows: 2.5 mg → 5 mg → 7.5 mg → 10 mg → 12.5 mg → 15 mg.

T1 group

HS-20094 MDV pen DRUG

The dose is escalated every 4 weeks until the target dose of 15 mg is reached. The dose escalation scheme is as follows: 2.5 mg → 5 mg → 7.5 mg → 10 mg → 12.5 mg → 15 mg.

T2 group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand the procedures and methods of this study, willing to strictly adhere to the clinical study protocol to complete this study, and voluntarily sign the informed consent form;
• Adult male or female participants (aged 18-65 years (inclusive), calculated based on the date of signing the informed consent form);
• Body mass index (BMI) ≥24.0 kg/m2 (BMI = weight (kg) / height2 (m2)); body weigh ≥45 kg for female participants and ≥50 kg for male participants.
• Self-reported diet/exercise control alone for at least 12 weeks prior to screening, with a weight change of ≤5% in the past 12 weeks (based on self-report); calculation formula for weight change: (highest weight - lowest weight within 12 weeks prior to screening) ∕ highest weight \* 100%;
• Agree to take effective contraceptive measures from the signing of the informed consent form until 8 weeks after the last dose, and have no plans for conception or sperm/egg donation during this period (only non-drug contraceptive measures are permitted during the study).

You may not qualify if:

• Participants with any of the following examination abnormalities at screening:
• Laboratory test results meet any of the following criteria (if there is a clear reason for retesting, one re-examination can be conducted within the time window of the screening period, and the results of this re-examination will be used as the basis for screening):
• HemoglobinA1c (HbA1c) ≥6.5% or fasting plasma glucose ≥7.0 mmol/L;
• Fasting plasma glucose \<2.8 mmol/L;
• Alanine aminotransferase \> 3 × ULN, or aspartate aminotransferase \> 3 × ULN, or total bilirubin \> 1.5 × ULN;
• Triglyceride \>500 mg/dL (5.64 mmol/L);
• Estimated glomerular filtration rate (absolute eGFR) based on the CKD-EPI equation \<60 mL/min;
• Serum calcitonin level ≥50 ng/L; ⑦ Thyroid-stimulating hormone \>6.0 mIU/L or \<0.4 mIU/L;
• ⑧ Blood amylase or blood lipase \>2×ULN;
• Prothrombin time (PT)-international normalized ratio (INR) exceeds the upper limit of normal, and the investigator determines the abnormality to be clinically significant, making it unsuitable for the participant to be enrolled; ⑩ Hemoglobin \<110 g/L (male) or \<100 g/L (female); ⑪ Positive test result for any one or more of the following items: hepatitis B surface antigen, hepatitis C antibody, HIV antibody/p24 antigen, or Treponema pallidum antibody;
• Presence of any of the following diseases or medical history prior to screening or randomization:
• Participants who currently have or with history of severe diseases involving nervous system, psychiatric system, digestive system, circulatory system, respiratory system, urinary system, etc., or have newly developed diseases before administration of the investigational product, and therefore are deemed by the investigator as unsuitable for participation in this study;
• Past history or ultrasound findings during screening period include any of the following conditions: medical history of chronic pancreatitis, acute pancreatitis, cholecystitis, or symptomatic/treatment-requiring gallbladder stones (except for participants who have undergone cholecystectomy but are deemed eligible for enrollment by the investigator);
• Participants with a history or family history of thyroid C-cell tumors or multiple endocrine neoplasia type 2;
• Participants with a history of metabolic disorders (such as unexplained recurrent hypoglycemia) who are deemed unsuitable for participation in this study upon the evaluation by the investigator;

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yu Cao

CONTACT

18661809090; caoyu1767@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: July 10, 2025
• Study Start: April 16, 2025
• Primary Completion: February 4, 2026
• Study Completion: May 29, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

CN (1)