Active not recruitingPhase 3

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Study to Evaluate the Efficacy and Safety of Zovaglutide in Adults With Overweight or Obesity.

Lead sponsor

Beijing QL Biopharmaceutical Co.,Ltd

Asset

Zovaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

755

Study population

Obesity / overweight

Eligibility highlights

Primary endpoints

•Body weight(%)•≥ 5% weight loss

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07230119

Org study IDBJQL-ZT002-3001

Timeline

Milestones

Study first posted2025-11-17actual

Study start2026-01-16actual

Last update posted2026-08-03actual

Primary completion2027-05-29estimated

Study completion2027-06-26estimated

Assets

Investigational agents

Zovaglutide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

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

•2.At screening and prior to randomization, BMI must meet one of the following criteria:

1. BMI≥28kg/m²regardless of comorbidities；

2. 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%.

Exclusion criteria

•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.

•5.History of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia (MEN2) in personal or family history.

•6.History of depression/anxiety disorder, or prior diagnosis of moderate-to-severe anxiety/depressive state, or history of severe psychiatric disorders;

•7. PHQ-9 scale score is ≥ 15 at screening;

•8. Screening C-SSRS questionnaire suicide ideation response of "Category 4 or 5," or any "yes" response to suicidal behavior questions.

Endpoints (13)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

8 endpoints

Primary/protocol endpoint

Change in body weight(%)

Time frame:baseline (week 0) to week 52

change from baseline, improvement

Primary/protocol endpoint

Proportion of subjects achieving ≥ 5% weight loss

Time frame:52 weeks

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of subjects achieving ≥10% weight loss

Time frame:week 52

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of subjects achieving ≥15% weight loss.

Time frame:week 52

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of subjects achieving ≥20% weight loss.

Time frame:week 52

threshold achievement, improvement

Secondary/protocol endpoint

Change in body weight (kg)

Time frame:Baseline (week 0) to week 52

change from baseline, improvement

Secondary/protocol endpoint

Change in BMI (kg/m²)

Time frame:Baseline (week 0) to week 52

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference (cm)

Time frame:Baseline (week 0) to week 52

change from baseline, improvement

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:Baseline (week 0) to week 56

event count, event

Secondary/protocol endpoint

Number of Serious Adverse Events (SAEs)

Time frame:Baseline (week 0) to week 56

event count, event

Secondary/protocol endpoint

Positive rate of anti-drug antibodies (ADA).

Time frame:Baseline (week 0) to week 56

descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Change in hip circumference (cm)

Time frame:Baseline (week 0) to week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Positive rate of neutralizing antibodies (Nab)

Time frame:Baseline (week 0) to week 56

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.