Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: T1 groupExperimental treatment 1 intervention
Group B: T2 groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From Day 1 to Day 169
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: Cmax

Time frame
From Day 1 to Day 169

Secondary outcomes

1

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

PK parameters following multiple doses at 10 mg administered via the HS-20094 MDV pen and AI pen: AUC0-168h;

Time frame
From Day 1 to Day 169
2

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

PK parameters following multiple doses at 10 mg administered via the HS-20094 MDV pen and AI pen: Cmax

Time frame
From Day 1 to Day 169
3

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

Adverse events

Time frame
From Day 1 to Day 204
4

Number of participants with Vital signs

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

Time frame
From Day 1 to Day 204

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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