ClinicalTrialsFinder
RecruitingPhase 1NCT07205432

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

Sponsor

Shanghai Xitaili Biomedicine Technology co., Ltd.

Enrollment

80 participants

Start Date

Jun 13, 2025

Study Type

INTERVENTIONAL

Conditions

Weight Management in Adult Patients With Obesity or Overweight

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria9

  • 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.

Exclusion Criteria15

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGXTL6001

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

DRUGPlacebo

This intervention contains no active ingredients

Locations(1)

Beijing Shijitan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07205432