DelfaGLP-1 Atlas

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Active not recruitingPhase 2

Efficacy and Safety of ZT006 in Overweight and Obese Participants

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Various Doses of ZT006 in Overweight and Obese Participants

Asset

ZT006

Subcutaneous · GLP-1 agonist

Listed sites

10

Recruiting sites

—

Enrollment

184

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥28

Primary endpoints

•Body weight relative•Treatment-emergent adverse events in the extension period•Serious adverse events in the extension period

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07230132
Org study IDBJQL-ZT006-2001

Timeline

Milestones

Study first posted2025-11-17actual
Study start2025-12-12actual
Last update posted2026-03-25actual
Primary completion2026-12-12estimated
Study completion2027-03estimated (month precision)

Assets

Investigational agents

ZT006

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

MAIN STUDY:

Inclusion Criteria:

•Male or female, age between 18 - 65 years (both inclusive) at the time of signing of the informed consent.
•Body mass index (BMI) greater than or equal to 28 kg/m², or greater than or equal to 24 kg/m²with at least one of the comorbidities: hypertension, hyperlipidemia, pre-diabetes, metabolic dysfunction-associated steatotic liver disease (MASLD) or obstructive sleep apnea-hypopnea syndrome (OSAHS).
•Having dietary caloric restriction and increased physical activity for ≥3 months, with change in body weight (increase or decrease) no more than 5%, irrespective of medical records.

Exclusion criteria

•Type 1 or type 2 diabetes or other specific types derived from other causes
•Medical history of acute or chronic pancreatitis
•Medical history of cholecystitis, gallstone ≤1 cm, or history of symptomatic gallbladder diseases
•Use of glucagon-like peptide-1 (GLP-1) agonist, dual GLP-1/glucose-dependent insulinotropic polypeptide (GIP) or GLP-1/glucagon agonist, or triple GLP-1/GIP/glucagon agonist within 90 days before screening
•HbA1c ≥ 6.5% or fasting plasma glucose ≥ 7.0 mmol/L at screening
•Triglyceride ≥ 5.7 mmol/L at screening
•Calcitonin ≥ 50 ng/L at screening

EXTENSION PERIOD:

Inclusion Criteria:

•Assigned to low/medium target dose groups in the main study and having completed week 28 visit in the main study
•Administration of low/medium target dose ≥ 10 times in the last two weeks in the main study

Exclusion Criteria:

•Participation in the dense PK sampling in the main study
•BMI ≤18.5 kg/m² at week 28 visit in the main study

Endpoints (14)

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
9
Safety / tolerability / PK
4
Other (unclassified)
1

Weight & body composition

9 endpoints
Primary/protocol endpoint

Change in body weight relative to baseline

Time frame:Percentage-point from baseline to end of treatment (week 28)of the main study

change from baseline, improvement

Secondary/protocol endpoint

Proportion of participants who achieved body weight reduction greater than or equal to 5% at week 28

Time frame:From baseline to end of treatment in the main study (week 28)

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of participants who achieved body weight reduction greater than or equal to 10% at week 28

Time frame:From baseline to end of treatment in the main study (week 28)

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of participants who achieved body weight reduction greater than or equal to 15% at week 28

Time frame:From baseline to end of treatment in the main study(week 28)

threshold achievement, improvement

Secondary/protocol endpoint

Change in body weight

Time frame:From baseline to end of treatment in the main study (week 28)

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:From baseline to end of treatment in the main study (week 28)

change from baseline, improvement

Secondary/protocol endpoint

Change in body mass index (BMI)

Time frame:From baseline to end of treatment in the main study (week 28)

change from baseline, improvement

Secondary/protocol endpoint

Change in body weight relative to baseline in the extension period

Time frame:From week 28 to week 40

change from baseline, improvement

Secondary/protocol endpoint

Change in body weight

Time frame:From week 28 to week 40

change from baseline, improvement

Safety / tolerability / PK

4 endpoints
Primary/protocol endpoint

Rate of treatment-emergent adverse events in the extension period

Time frame:From week 28 to week 45

descriptive

Primary/protocol endpoint

Rate of serious adverse events in the extension period

Time frame:From week 28 to week 45

descriptive

Secondary/protocol endpoint

Rate of treatment-emergent adverse events

Time frame:From baseline to end of the main study (week 33)

descriptive

Secondary/protocol endpoint

Rate of serious adverse events

Time frame:From baseline to end of the main study (week 33)

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Proportion of participants with positive anti-ZT006 antibody

Time frame:From baseline to end of treatment in the main study (week 33)

threshold achievement, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 July 1, 2026 snapshot.