Phase I Study of XTL6001 Injection in Healthy and Obese Subjects

NCT07205432 | Recruiting Phase 1

• 1 other identifier: XTL6001-I-C01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (15)

• 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.

• 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.

• 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.

• 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-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.

Study Arms (2)

XTL6001

EXPERIMENTAL

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

Drug: XTL6001

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

XTL6001 DRUG

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

XTL6001

Placebo DRUG

This intervention contains no active ingredients

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and \< 65 years at screening.
• Body mass index (BMI) ≥ 18.5 kg/m² and \< 28.0 kg/m² at screening.
• Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening.
• Signed informed consent form prior to the trial, with full understanding of the study objectives, procedures, and potential adverse reactions.
• Age ≥ 18 and \< 65 years at screening.
• BMI ≥ 18.5 kg/m2且 \< 40.0kg/m².
• Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening.
• Stable body weight (fluctuation \< 5%) for at least 3 months prior to screening.
• Signed informed consent form prior to the trial, with full understanding of the study objectives, procedures, and potential adverse reactions.

You may not qualify if:

• History of type 1 or type 2 diabetes mellitus, or HbA1c \> 6.5% or fasting plasma glucose \> 7.0 mmol/L at screening.
• Clinically significant gastric emptying disorders, chronic use of medications directly affecting gastrointestinal motility, severe chronic gastrointestinal diseases, or prior gastrointestinal surgery.
• History of acute or chronic pancreatitis.
• Symptomatic gallbladder disease.
• Malignancy within 5 years prior to screening (except adequately treated non-melanoma skin cancer).
• Personal/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2A/2B (MEN 2A/2B).
• Female subjects with positive pregnancy test or lactation.
• History of type 1 or type 2 diabetes mellitus, or HbA1c \> 6.5% or fasting plasma glucose \> 7.0 mmol/L at screening.
• UnderlyingCushing's syndrome, hypothyroidism, PCOS,.
• 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.
• History of acute or chronic pancreatitis.
• Symptomatic gallbladder disease.
• Malignancy within 5 years prior to screening (except adequately treated non-melanoma skin cancer).
• Personal/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2A/2B (MEN 2A/2B).
• Female subjects with positive pregnancy test or lactation.

Sponsors & Collaborators

• Shanghai Xitaili Biomedicine Technology co., Ltd.: lead

Study Sites (1)

Beijing Shijitan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100038, China

RECRUITING

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xiao Hua Hao, Ph.D. in Medicine

CONTACT

010-63926883; xiaohualuck@sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: October 3, 2025
• Study Start: June 13, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-04

Locations

CN (1)