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RecruitingPhase 1

Phase I Study of XTL6001 Injection in Healthy and Obese Subjects

A Randomized, Double-blind, Placebo-controlled Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Administration of XTL6001 Injection in Healthy and Obese Subjects

Asset

GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

1

Enrollment

80

estimated

Study population

Healthy volunteers, Obesity / overweight

Key I/E criterion

BMI ≥18.5

Primary endpoint

Treatment-emergent AEs (any) (Treatment-emergent AEs (any), Serious AEs (any))

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 IDNCT07205432
Org study IDXTL6001-I-C01

Timeline

Milestones

Study start2025-06-13actual
Study first posted2025-10-03actual
Last update posted2025-10-03actual
Primary completion2026-04estimated (month precision)
Study completion2026-04estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

Inclusion Criteria for Subjects in SAD part:

1. Age ≥ 18 and < 65 years at screening.

2. Body mass index (BMI) ≥ 18.5 kg/m² and < 28.0 kg/m² at screening.

3. Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening.

4. Signed informed consent form prior to the trial, with full understanding of the study objectives, procedures, and potential adverse reactions.

Inclusion Criteria for Subjects in MAD part:

1. Age ≥ 18 and < 65 years at screening.

2. BMI ≥ 18.5 kg/m2且 < 40.0kg/m².

3. Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening.

4. Stable body weight (fluctuation < 5%) for at least 3 months prior to screening.

5. Signed informed consent form prior to the trial, with full understanding of the study objectives, procedures, and potential adverse reactions.

Exclusion criteria

Exclusion Criteria for Subjects in SAD part:

1. History of type 1 or type 2 diabetes mellitus, or HbA1c > 6.5% or fasting plasma glucose > 7.0 mmol/L at screening.

2. Clinically significant gastric emptying disorders, chronic use of medications directly affecting gastrointestinal motility, severe chronic gastrointestinal diseases, or prior gastrointestinal surgery.

3. History of acute or chronic pancreatitis.

4. Symptomatic gallbladder disease.

5. Malignancy within 5 years prior to screening (except adequately treated non-melanoma skin cancer).

6. Personal/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2A/2B (MEN 2A/2B).

7. Female subjects with positive pregnancy test or lactation.

Exclusion Criteria for Subjects in MAD part:

1. History of type 1 or type 2 diabetes mellitus, or HbA1c > 6.5% or fasting plasma glucose > 7.0 mmol/L at screening.

2. UnderlyingCushing's syndrome, hypothyroidism, PCOS,.

3. Clinically significant gastric emptying disorders, chronic use of medications directly affecting gastrointestinal motility, severe chronic gastrointestinal diseases, or gastrointestinal surgeries that may compromise safety or data interpretation.

4. History of acute or chronic pancreatitis.

5. Symptomatic gallbladder disease.

6. Malignancy within 5 years prior to screening (except adequately treated non-melanoma skin cancer).

7. Personal/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2A/2B (MEN 2A/2B).

8. Female subjects with positive pregnancy test or lactation.

Endpoints (16)

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

Safety / tolerability / PK
8
Weight & body composition
4
Glycemic / diabetes
2
Cardiometabolic biomarkers
1
Other (unclassified)
1

Weight & body composition

4 endpoints
Secondary/protocol endpoint

Body weight

Time frame:MAD: up to Day57

descriptive, improvement

Secondary/protocol endpoint

Body mass index (BMI)

Time frame:MAD: up to Day57

descriptive

Secondary/protocol endpoint

Waist circumference

Time frame:MAD: up to Day57

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Waist-to-hip ratio

Time frame:MAD: up to Day57

ratio, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint/low confidence

Blood glucose

Time frame:MAD: up to Day57

descriptive, improvement

Secondary/protocol endpoint/low confidence

Insulin

Time frame:MAD: up to Day57

descriptive

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Blood lipids

Time frame:MAD: up to Day57

change from baseline, improvement

Safety / tolerability / PK

8 endpoints
Primary/protocol endpoint

Incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events)

Time frame:SAD: up to Day 8 MAD: up to Day 57

Treatment-emergent AEs (any)

descriptive, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Secondary/protocol endpoint

The maximum plasma concentration (Cmax) of XTL6001

Time frame:Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.

Cmax

concentration, descriptive

Secondary/protocol endpoint

Tmax of XTL6001

Time frame:Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.

Tmax

descriptive

Secondary/protocol endpoint

Elimination half-life (T1/2) of XTL6001

Time frame:Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.

Half-life

descriptive

Secondary/protocol endpoint

Area under the plasma concentration-time curve during one dosing interval (AUC) 0-tau of XTL6001

Time frame:Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

AUC0-t of XTL6001

Time frame:Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Anti-drug antibodies (ADA)

Time frame:MAD: up to Day57

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

ADA

Time frame:MAD: up to D57

Immunogenicity (ADA)

time to event, event

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Uric acid

Time frame:MAD: up to Day57

change from baseline, 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.