New Triple-Action weight loss drug enters first human safety tests

NCT ID NCT07205432

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests a new injection called XTL6001 in 80 healthy and obese adults. The main goal is to check safety and how the body processes the drug. Researchers will also look at weight changes, but the study is too small to prove effectiveness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
XTL6001 injection (a triple-target GLP-1 receptor agonist for weight management)
What this could lead to
If successful, this could lead to a new injectable medication for weight loss and metabolic disease management.
What could go wrong
This is an early Phase 1 trial with only 80 participants, focused on safety. It is too small and early to know if XTL6001 will be effective or have serious side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Shijitan Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 100038, China