Phase I Study of XTL6001 Injection in Healthy and Obese Subjects

Not Applicable

Recruiting

• Conditions: Weight Management in Adult Patients With Obesity or Overweight
• Interventions: Drug: XTL6001; Drug: Placebo

• Registration Number: NCT07205432
• Lead Sponsor: Shanghai Xitaili Biomedicine Technology co., Ltd.

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase I study to evaluate safety, PK and PD of single ascending dose (SAD) and multiple ascending dose (MAD) of XTL6001 injection in healthy and obese adult subjects.

SAD study: Includes 5 dose cohorts, with 40 subjects planned for enrollment. MAD study Includes 2 dose cohorts, with 30 subjects planned for enrollment.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-06-13
• Study First Submitted: 2025-07-28
• Study First Submitted QC: 2025-09-25
• Last Update Submitted: 2025-09-25
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03
• Primary Completion: 2026-04
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
XTL6001	XTL6001	Interventional: The SAD study involves single administration of XLT6001, while the MAD study involves administration of XLT6001 for no more than 4 weeks.
Placebo	Placebo	Placebo: The SAD study involves single administration of Placebo, while the MAD study involves administration of Placebo for no more than 4 weeks.

Primary Outcome Measures

Name	Time	Method
Incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events)	SAD: up to Day 8 MAD: up to Day 57

Secondary Outcome Measures

Name	Time	Method
Tmax of XTL6001	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.	The time to maximum concentration (Tmax) of XTL6001
The maximum plasma concentration (Cmax) of XTL6001	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 - Maximum plasma concentration
Body weight	MAD: up to Day57	Body weight
Body mass index （BMI）	MAD: up to Day57	Body mass index
Elimination half-life (T1/2) of XTL6001	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.	t1/2 - Elimination half-life
Area under the plasma concentration-time curve during one dosing interval (AUC) 0-tau of XTL6001	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-tau - Area under the plasma concentration-time curve during one dosing interval
AUC0-t of XTL6001	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-t - Area under the plasma concentration-time curve from time zero to the last measurable concentration
Uric acid	MAD: up to Day57	Uric acid
Waist circumference	MAD: up to Day57	waist circumference
Waist-to-hip ratio	MAD: up to Day57	waist-to-hip ratio
Blood lipids	MAD: up to Day57	Total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, apolipoprotein A1 and apolipoprotein B
Blood glucose	MAD: up to Day57	Blood glucose
Insulin	MAD: up to Day57	Insulin
Anti-drug antibodies (ADA)	MAD: up to Day57	Incidence of anti-drug antibodies (ADA)
ADA	MAD: up to D57	Time to ADA positivity

Trial Locations

Locations (1)

Beijing Shijitan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing Municipality, China