Overweight and Obese VolunteersPhase 1NCT06493084
Evaluate LAE102 in Healthy and Overweight/Obese Subjects
A Phase 1 study testing LAE102 intravenous administration, LAE102 subcutaneous administration and LAE102 multiple subcutaneous administration in people with Overweight and Obese Volunteers, run by Laekna Limited at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of LAE102 injection in healthy and overweight/obese participants, and also evaluate the preliminary pharmacodynamic effect of multiple dose injections in overweight/obese participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obese Volunteers
- What is being tested?
- LAE102 intravenous administration, LAE102 subcutaneous administration and LAE102 multiple subcutaneous administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2024to 30 Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female and aged 18 to 65 years (inclusive) at the screening visit
- Male Body weight ≥ 50 kg, female Body weight ≥ 45 kg. For Part A\&B, 18.5 ≤ BMI ≤ 28 kg/m². For part C, 26.0 ≤ BMI ≤ 40.0 kg/m²
- Negative for human immunodeficiency virus antibody (HIV-Ab).
- Female subjects with no childbearing potential or with childbearing potential which serum human chorionic gonadotropin (hCG) test must <5mIU/mL .
- Male subjects are not allowed to donate sperm during this trial.
- Voluntarily participate in the study and provide a signed and dated informed consent form.
- Willing to comply with the scheduled visits, study treatment, laboratory tests, and other study-related procedures and requirements as stipulated in the study protocol.
Who cannot join
- With clinically significant abnormalities in vital signs, physical examination, ECG or laboratory test results specified in the protocol.
- Allergy to the investigational drug or its excipients, or a history of severe allergy (including any food or drug allergies).
- Self-reported weight change is more than 5% in the previous 3 months prior to screening.
- Diagnosed with secondary overweight or obesity.
- Any clinically significant medical conditions and any diseases affecting the safety of the subject or the determination of study results.
- History of major diseases or physical conditions in the central nervous system, respiratory system, cardiovascular system, digestive system, blood system, endocrine system, musculoskeletal diseases, mental illness, urinary system, or tumors, or any existing acute diseases, or other diseases or physical conditions that may affect the study or pose an unacceptable risk to the subjects.
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- Positive for hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV-Ab), or syphilis spirochete antibody (TP-Ab).
- Known or suspected history of substance abuse or positive drug screening test.
- Alcohol abuse within 1 year before screening or positive alcohol breath test at baseline.
- Smoking more than 5 cigarettes per day within 3 months before screening, or unable to comply with the prohibition of smoking during the study period.
- Received any vaccine within 30 days prior to screening, or planned to receive any vaccine during the study period.
- Inability to ensure no use of any drugs, including prescription and non-prescription drugs (excluding paracetamol, ibuprofen, and topically applied eye/nasal drops and ointments with no systemic exposure risk), vitamins, supplements and herbal medicines, from 14 days before the initial administration (if the half-life of the drug used exceeds 14 days, then 5 half-lives shall apply) until the last visit period.
- Participated in any clinical trial and received an investigational medicine or medical device within 3 months prior to dosing of the investigational product.
- Underwent major surgery within 30 days before the initial administration or planned to undergo major surgery during the study period.
- Donated blood or experienced blood loss ≥400 mL within 3 months before screening or received a blood transfusion.
- Have special dietary requirements and cannot comply with a standardized diet.
- History of fainting or syncope.
- Dieting or receiving weight loss treatment within 30 days before the initial administration or experiencing major changes in lifestyle.
- Use of GLP-1 receptor agonists, or weight loss medications or systemic corticosteroids (oral or intravenous for more than 7 days), or psychiatric medications within 3 months prior to the initial administration. Applicable to part C.
- Regular engaged in muscle strength related exercise, applicable to part C.
- Other situation that the investigator considers not appropriate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan Zhongshan Hospital
Shanghai, Shanghai Municipality, 201203
Xuening Li, Professor, li.xuening@zs-hospital.sh.cn
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose Escalation Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LAE102 Injection in Healthy and Overweight/Obese Subjects
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of LAE102 injection in healthy and overweight/obese participants, and also evaluate the preliminary pharmacodynamic effect of multiple dose injections in overweight/obese participants.
Read the detailed description
Part A is a randomized, double-blinded, placebo-controlled, single ascending dose by Intravenous (IV) administration in 40 Healthy participants;
Part B is a randomized, double-blinded, placebo-controlled, single ascending dose by subcutaneous (SC) administration in 24 Healthy participants;
Part C is a randomized, double-blind, placebo-controlled, multiple dose ascending and expanding by subcutaneous (SC) administration in 60 overweight/obese participants.
- Conditions
- Overweight and Obese Volunteers
- Being tested
- LAE102 intravenous administration, placebo intravenous administration, LAE102 subcutaneous administration, placebo subcutaneous administration, LAE102 multiple subcutaneous administration
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAE102 intravenous administrationDrug
Also called LAE102 IV
A single dose of LAE102 administered intravenously
placebo intravenous administrationDrug
Also called Placebo IV
A single dose of placebo administered intravenously
LAE102 subcutaneous administrationDrug
Also called LAE102 SC
Single dose of LAE102 administered subcutaneously
placebo subcutaneous administrationDrug
Also called Placebo SC
single dose of placebo administered subcutaneously
LAE102 multiple subcutaneous administrationDrug
Also called LAE102 SC
Multiple dose of LAE102 administered subcutaneously
Placebo multiple subcutaneous administrationDrug
Also called Placebo SC
Multiple dose of placebo administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Part A LAE102 IV | Experimental | Single dose LAE102 by IV administration Receives: Drug: LAE102 intravenous administration |
| Part A placebo IV | Placebo comparator | Single dose placebo by IV administration Receives: Drug: placebo intravenous administration |
| Part B LAE102 SC | Experimental | Single dose LAE102 by SC administration Receives: Drug: LAE102 subcutaneous administration |
| Part B placebo SC | Placebo comparator | Single dose placebo by SC administration Receives: Drug: placebo subcutaneous administration |
| Part C LAE102 SC | Experimental | Multiple dose LAE102 by SC administration Receives: Drug: LAE102 multiple subcutaneous administration |
| Part C placebo SC | Placebo comparator | Multiple dose placebo by SC administration Receives: Drug: Placebo multiple subcutaneous administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number & severity of participants with treatment-related adverse events as assessed by CTCAE V5.0
Findings on physical examination, ECG, vital signs, and reports of the laboratory results based on the CTCAE v5.0
Measured: From Day 1 to Day 29 for single dose part. From Day 1 to Day 196 for multiple dose part
Secondary outcomes (4)
characterize the peak of serum concentration (Cmax) of LAE102 injection in healthy subjects
For both intravenously guttae \& subcutaneous injection, to evaluate the maximum observed serum concentration(Cmax)
Measured: From pre-dose to Day 29 for single dose part. From pre-dose to Day 196 for multiple dose part.
characterize the area under the serum concentration versus time curve (AUC) of LAE102 injection in healthy subjects
For both intravenously guttae \& subcutaneous injection, to evaluate the area under the serum concentration versus time curve (AUC)
Measured: From pre-dose to Day 29 for single dose part. From pre-dose to Day 196 for multiple dose part.
evaluate the expression levels of Activin A in blood samples
The validated methodology was employed to assay serum levels of Activin A in biological samples.
Measured: From pre-dose to Day 29 for single dose part. From pre-dose to Day 196 for multiple dose part.
Incidence of positive Anti-drug antibody(ADA) after administration
Test ADA status in biological sample via validated methodology
Measured: pre-dose to Day 29 for single dose part. From pre-dose to Day 196 for multiple dose part.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start25 Jun 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and Obese VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laekna Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xuening Li, Professor, Principal investigator, Zhongshan hospital affiliated to Fundan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493084
- Sponsor's protocol ID
- LAE102CN1001
- Status last verified
- Jan 2026
- First submitted
- 3 Jun 2024
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose Escalation Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LAE102 Injection in Healthy and Overweight/Obese Subjects
- ClinicalTrials.gov ID
- NCT06493084
- Acronym / sponsor ID
- LAE102CN1001
- Conditions
- Overweight and Obese Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Laekna LimitedIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of LAE102 injection in healthy and overweight/obese participants, and also evaluate the preliminary pharmacodynamic effect of multiple dose injections in overweight/obese participants.
Detailed description
Part A is a randomized, double-blinded, placebo-controlled, single ascending dose by Intravenous (IV) administration in 40 Healthy participants;
Part B is a randomized, double-blinded, placebo-controlled, single ascending dose by subcutaneous (SC) administration in 24 Healthy participants;
Part C is a randomized, double-blind, placebo-controlled, multiple dose ascending and expanding by subcutaneous (SC) administration in 60 overweight/obese participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A LAE102 IV | Experimental | Drug: LAE102 intravenous administrationSingle dose LAE102 by IV administration |
| Part A placebo IV | Placebo comparator | Drug: placebo intravenous administrationSingle dose placebo by IV administration |
| Part B LAE102 SC | Experimental | Drug: LAE102 subcutaneous administrationSingle dose LAE102 by SC administration |
| Part B placebo SC | Placebo comparator | Drug: placebo subcutaneous administrationSingle dose placebo by SC administration |
| Part C LAE102 SC | Experimental | Drug: LAE102 multiple subcutaneous administrationMultiple dose LAE102 by SC administration |
| Part C placebo SC | Placebo comparator | Drug: Placebo multiple subcutaneous administrationMultiple dose placebo by SC administration |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female and aged 18 to 65 years (inclusive) at the screening visit
- Male Body weight ≥ 50 kg, female Body weight ≥ 45 kg. For Part A\&B, 18.5 ≤ BMI ≤ 28 kg/m². For part C, 26.0 ≤ BMI ≤ 40.0 kg/m²
- Negative for human immunodeficiency virus antibody (HIV-Ab).
- Female subjects with no childbearing potential or with childbearing potential which serum human chorionic gonadotropin (hCG) test must <5mIU/mL .
- Male subjects are not allowed to donate sperm during this trial.
Key exclusion criteria (21 listed)
- With clinically significant abnormalities in vital signs, physical examination, ECG or laboratory test results specified in the protocol.
- Allergy to the investigational drug or its excipients, or a history of severe allergy (including any food or drug allergies).
- Self-reported weight change is more than 5% in the previous 3 months prior to screening.
- Diagnosed with secondary overweight or obesity.
- Any clinically significant medical conditions and any diseases affecting the safety of the subject or the determination of study results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAE102 intravenous administrationAlso: LAE102 IVA single dose of LAE102 administered intravenously | Drug | Part A LAE102 IV |
| placebo intravenous administrationAlso: Placebo IVA single dose of placebo administered intravenously | Drug | Part A placebo IV |
| LAE102 subcutaneous administrationAlso: LAE102 SCSingle dose of LAE102 administered subcutaneously | Drug | Part B LAE102 SC |
| placebo subcutaneous administrationAlso: Placebo SCsingle dose of placebo administered subcutaneously | Drug | Part B placebo SC |
| LAE102 multiple subcutaneous administrationAlso: LAE102 SCMultiple dose of LAE102 administered subcutaneously | Drug | Part C LAE102 SC |
| Placebo multiple subcutaneous administrationAlso: Placebo SCMultiple dose of placebo administered subcutaneously | Drug | Part C placebo SC |
Primary outcome
Number & severity of participants with treatment-related adverse events as assessed by CTCAE V5.0
Time frame: From Day 1 to Day 29 for single dose part. From Day 1 to Day 196 for multiple dose part
Findings on physical examination, ECG, vital signs, and reports of the laboratory results based on the CTCAE v5.0
4 secondary outcomes
characterize the peak of serum concentration (Cmax) of LAE102 injection in healthy subjects
Time frame: From pre-dose to Day 29 for single dose part. From pre-dose to Day 196 for multiple dose part.
characterize the area under the serum concentration versus time curve (AUC) of LAE102 injection in healthy subjects
Time frame: From pre-dose to Day 29 for single dose part. From pre-dose to Day 196 for multiple dose part.
evaluate the expression levels of Activin A in blood samples
Time frame: From pre-dose to Day 29 for single dose part. From pre-dose to Day 196 for multiple dose part.
Incidence of positive Anti-drug antibody(ADA) after administration
Time frame: pre-dose to Day 29 for single dose part. From pre-dose to Day 196 for multiple dose part.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xuening Li, Professor principal investigator
Zhongshan hospital affiliated to Fundan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LAE102 intravenous administration, LAE102 subcutaneous administration and LAE102 multiple subcutaneous administration in people with Overweight and Obese Volunteers, run by Laekna Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Qiu, BS (+8617310793626, li.qiu@laekna.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number & severity of participants with treatment-related adverse events as assessed by CTCAE V5.0 (time frame: From Day 1 to Day 29 for single dose part. From Day 1 to Day 196 for multiple dose part). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.