Health TrialsbyHealthPanel

A Study of Zovaglutide in Subjects With Overweight or Obesity (HORIZON-1)

ConditionOverweight , Obesity
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing QL Biopharmaceutical Co.,Ltd

About this trial

This study will evaluate the percentage change in body weight from baseline and proportion of subjects achieving ≥ 5% weight loss from baseline after 52 weeks of treatment with Zovaglutide in subjects with overweight/obesity.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Male or female subjects aged≥18years and≤75 years at the time of signing the ICF.

BMI≥28kg/m²regardless of comorbidities；

BM≤24 kg/m² and<28 kg/m², with at least one of the following comorbidities: prediabetes, hypertension, dyslipidemia, fatty liver disease, obstructive sleep apnea syndrome due to overweight, or weight-bearing joint pain.

3.Weight change due to diet and exercise alone within 3 months prior to screening and randomization did not exceed 5%.

Disqualifiers

1.Previously diagnosed obesity caused by monogenic mutations, other diseases, or medications.

2.Previous diagnosis of diabetes; or HbA1c ≥ 6.5% or fasting blood glucose ≥ 7.0 mmol/L at screening.

3.Used of medicines or treatments that affect weight within 3 months prior to screening.

4.History of acute or chronic pancreatitis, or pancreatic injury.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Zovaglutide dose 1

    Drug

    administered subcutaneously (SC), Q4W

  • Zovaglutide dose 2

    Drug

    administered subcutaneously (SC), Q4W

  • Placebo

    Drug

    administered subcutaneously (SC), Q4W

Treatment groups

744 Participants
are divided into 3 treatment groups
Group A: Zovaglutide dose 1Experimental treatment 1 intervention
Group B: Zovaglutide dose 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in body weight(%)

Time frame
baseline (week 0) to week 52
2

Proportion of subjects achieving ≥ 5% weight loss

Time frame
52 weeks

Secondary outcomes

1

Proportion of subjects achieving ≥10% weight loss

Time frame
week 52
2

Proportion of subjects achieving ≥15% weight loss.

Time frame
week 52
3

Proportion of subjects achieving ≥20% weight loss.

Time frame
week 52
4

Change in body weight (kg)

Time frame
Baseline (week 0) to week 52

Other outcomes

Sponsors and contacts

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

Beijing QL Biopharmaceutical Co.,Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: