OverweightPhase 1NCT05548231
A Study of LY3437943 in Chinese Participants With Obesity Or Overweight
A Phase 1 study testing LY3437943 in people with Overweight and Obesity, run by Eli Lilly and Company at 2 sites in China.
Trial summary
The main purpose of this study is to learn about the safety and tolerability of LY3437943 when given to Chinese participants with overweight body mass index (BMI) or obesity. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- LY3437943
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 2 sitesChina
- Study dates
- 24 Oct 2022to 27 Jul 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For All Participants:
- Are native Chinese males or females
- Have a body mass index of ≥27 and ≤40 kilograms per square meter (kg/m²)
- Have not modified diet or adopted any nutritional lifestyle modification for 3 months
- Have stable body weight for the last three months
- Male participants must agree to use contraception during the study and for 4 months afterward and female participants must be woman of nonchildbearing potential
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- For Type 2 Diabetes Mellitus (T2DM) Participants:
- Have type 2 diabetes for at least 3 months
- Have a glycated hemoglobin (HbA1c) value of ≥7.0% and ≤10.5% and have been treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening
Who cannot join
- For All Participants:
- Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week and smoke more than 10 cigarettes, or cigarette equivalent (as determined by investigator), per day
- Have other serious or unstable illnesses
- Have had an episode of severe hypoglycemia
- Current or chronic history of liver disease.
- For T2DM Participants:
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- Have type 1 diabetes mellitus
- Have uncontrolled diabetes, defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization
- Any glucose-lowering medications other than metformin within 3 months prior to screening
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking University First Hospital
Beijing, 100034
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
About this study
Official title: A Multiple Dose Escalation Study in Chinese Participants With Overweight BMI or Obesity to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3437943
The main purpose of this study is to learn about the safety and tolerability of LY3437943 when given to Chinese participants with overweight body mass index (BMI) or obesity. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Each enrolled participant will receive injections of LY3437943 or placebo given just under the skin. For each participant, the study will last about 20 weeks excluding screening period and may include up to 20 visits to the study center.
- Conditions
- Overweight, Obesity
- Being tested
- LY3437943, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3437943Drug
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| LY3437943 | Experimental | LY3437943 administered subcutaneously (SC) Receives: Drug: LY3437943 |
| Placebo | Placebo comparator | Placebo administered SC Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline through Week 20
Secondary outcomes (2)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943
PK: Cmax of LY3437943
Measured: Predose through Day 109
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3437943
PK: AUC of LY3437943
Measured: Predose through Day 109
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start24 Oct 2022
- Primary completion27 Jul 2023
- Study completion27 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548231
- Sponsor's protocol ID
- 17954
- Other IDs
- J1I-MC-GZBE
- Status last verified
- Aug 2023
- First submitted
- 16 Sep 2022
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose Escalation Study in Chinese Participants With Overweight BMI or Obesity to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3437943
- ClinicalTrials.gov ID
- NCT05548231
- Acronym / sponsor ID
- 17954
- Conditions
- Overweight, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 27 Jul 2023 (actual)
- Study completion
- 27 Jul 2023 (actual)
- First posted
- 21 Sep 2022 (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 main purpose of this study is to learn about the safety and tolerability of LY3437943 when given to Chinese participants with overweight body mass index (BMI) or obesity. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Each enrolled participant will receive injections of LY3437943 or placebo given just under the skin. For each participant, the study will last about 20 weeks excluding screening period and may include up to 20 visits to the study center.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY3437943 | Experimental | Drug: LY3437943LY3437943 administered subcutaneously (SC) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered SC |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Are native Chinese males or females
- Have a body mass index of ≥27 and ≤40 kilograms per square meter (kg/m²)
- Have not modified diet or adopted any nutritional lifestyle modification for 3 months
- Have stable body weight for the last three months
- Male participants must agree to use contraception during the study and for 4 months afterward and female participants must be woman of nonchildbearing potential
Key exclusion criteria (9 listed)
- Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week and smoke more than 10 cigarettes, or cigarette equivalent (as determined by investigator), per day
- Have other serious or unstable illnesses
- Have had an episode of severe hypoglycemia
- Current or chronic history of liver disease.
- Have type 1 diabetes mellitus
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 |
|---|---|---|
| LY3437943Administered SC | Drug | LY3437943 |
| PlaceboAdministered SC | Drug | Placebo |
Primary outcome
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline through Week 20
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
2 secondary outcomes
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943
Time frame: Predose through Day 109
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3437943
Time frame: Predose through Day 109
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- 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. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3437943 in people with Overweight and Obesity, run by Eli Lilly and Company at 2 sites 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 9 inclusion and 9 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: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline through Week 20). 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 14 Aug 2023.