A Study of HS-20094 in Overweight or Obese Participants
ConditionOverweight or Obesity
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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%;
Disqualifiers
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);
Trial design
Treatments tested in this trial
- HS-20094 AI pen;
- HS-20094 MDV pen
Treatment groups
144 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov