Phase I Study of XTL6001 Injection in Healthy and Obese Subjects

NCT ID: NCT07205432

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-13
• Study Completion Date: 2026-04-30

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.

Conditions

Weight Management in Adult Patients With Obesity or Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

XTL6001

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

Group Type: EXPERIMENTAL

XTL6001

Intervention Type: DRUG

XTL6001 is a triple-target Glucagon-like peptide-1 receptor （GLP-1R） relevant agonist, intending to manage overweight/obesity and other metabolic diseases

Placebo

Placebo: The SAD study involves single administration of Placebo, while the MAD study involves administration of Placebo for no more than 4 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

This intervention contains no active ingredients

Interventions

XTL6001

XTL6001 is a triple-target Glucagon-like peptide-1 receptor （GLP-1R） relevant agonist, intending to manage overweight/obesity and other metabolic diseases

Intervention Type: DRUG

Placebo

This intervention contains no active ingredients

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.

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

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Xitaili Biomedicine Technology co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Shijitan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiao Hua Hao, Ph.D. in Medicine

Role: CONTACT

xiaohualuck@sina.com

010-63926883

Facility Contacts

Xiao Hua Hao, Ph.D. in Medicine

Role: primary

xiaohualuck@sina.com

010-63926883

Other Identifiers

XTL6001-I-C01

Identifier Type: -

Identifier Source: org_study_id