ObesityPhase 1NCT06313528
A Study to Measure Calorie Consumption and Usage in Participants With Obesity Using LY3437943
A Phase 1 study testing LY3437943 in people with Obesity, run by Eli Lilly and Company at 3 sites in United States.
Trial summary
The main purpose of the study is to look at the effect of the study drug compared to placebo on calorie intake, energy metabolism, and appetite. The study will last up to 6 months and may include up to 20 visits. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- 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
- 85 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Mar 2024to 26 Aug 2025
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI greater than 30 kg/m2
- History of at least 1 self-reported unsuccessful dietary effort to reduce body weight
Who cannot join
- Change in body weight of greater than 5 kg (11 pounds) within 3 months prior to start of study
- Any of the following treatments for obesity within 1 year prior, or plan to undergo any of these during the study period: liposuction, cryolipolysis, or abdominoplasty
- Prior or planned bariatric or gastric sleeve surgery, endoscopic therapy, or device-based therapy for obesity
- Type 1 or Type 2 Diabetes, history of ketoacidosis, or hyperosmolar state
- Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome Type 2
- Acute or chronic hepatitis
Show all 13Show fewer
- Had within 90 days prior: acute myocardial infarction, cerebrovascular accident (stroke), coronary artery revascularization, hospitalization for unstable angina, or hospitalization due to congestive heart failure
- History of active or unstable major depressive disorder or other severe psychiatric disorder within 2 years prior
- History of chronic or acute pancreatitis
- Blood transfusion or severe blood loss within the last 3 months or hemoglobinopathy, hemolytic anemia, sickle cell anemia
- Clinically significant multiple or severe drug allergies
- Started treatment with or changed dose within 12 months prior any medications that are associated with significant weight gain
- History of substance use disorder
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Columbia University Irving Medical Center
New York, New York, 10032
AdventHealth Orlando
Orlando, Florida, 32804
About this study
Official title: A Randomized, Double-Blind, Phase 1 Study to Investigate the Effect of LY3437943 Versus Placebo on Calorie Intake and Energy Expenditure in Participants With Obesity Under Calorie Restriction
The main purpose of the study is to look at the effect of the study drug compared to placebo on calorie intake, energy metabolism, and appetite. The study will last up to 6 months and may include up to 20 visits.
- Conditions
- Obesity
- Being tested
- LY3437943, Placebo
- Keywords
- Food, Diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3437943Drug
Administered SC
PlaceboOther
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| LY3437943 | Experimental | LY3437943 administered subcutaneously (SC) Receives: Drug: LY3437943 |
| Placebo | Placebo comparator | Placebo administered SC Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Total Calorie Intake at Lunch and Dinner (Combined)
Measured: Baseline up to Week 17 (inclusive)
Secondary outcomes (7)
Change from Baseline in Sleep Metabolic Rate (SMR)
In participants who achieve target weight loss
Measured: Baseline up to Week 16 (inclusive)
Change from Baseline in SMR
Measured: Baseline up to Week 16 (inclusive)
Change from Baseline in 24-hour Energy Expenditure (EE)
In participants who achieve target weight loss
Measured: Baseline up to Week 16 (inclusive)
Change from Baseline in 24-hour EE
Measured: Baseline up to Week 16 (inclusive)
Change from Baseline in Total Calorie Intake at Lunch
Measured: Baseline up to Week 17 (inclusive)
Change from Baseline in Total Calorie Intake at Dinner
Measured: Baseline up to Week 17 (inclusive)
Change from Baseline in Fasting Appetite Visual Analog Score (VAS)
Measured: Baseline up to Week 16 (inclusive)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start20 Mar 2024
- Primary completion26 Aug 2025
- Study completion26 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 85 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
- NCT06313528
- Sponsor's protocol ID
- 18726
- Other IDs
- J1I-MC-GZBW
- Status last verified
- Sep 2025
- First submitted
- 11 Mar 2024
- Last updated
- 23 Sep 2025
- 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 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Phase 1 Study to Investigate the Effect of LY3437943 Versus Placebo on Calorie Intake and Energy Expenditure in Participants With Obesity Under Calorie Restriction
- ClinicalTrials.gov ID
- NCT06313528
- Acronym / sponsor ID
- 18726
- Conditions
- Obesity
- Keywords
- Food, Diet
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 26 Aug 2025 (actual)
- Study completion
- 26 Aug 2025 (actual)
- First posted
- 15 Mar 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 main purpose of the study is to look at the effect of the study drug compared to placebo on calorie intake, energy metabolism, and appetite. The study will last up to 6 months and may include up to 20 visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY3437943 | Experimental | Drug: LY3437943LY3437943 administered subcutaneously (SC) |
| Placebo | Placebo comparator | Other: PlaceboPlacebo administered SC |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI greater than 30 kg/m2
- History of at least 1 self-reported unsuccessful dietary effort to reduce body weight
Key exclusion criteria (13 listed)
- Change in body weight of greater than 5 kg (11 pounds) within 3 months prior to start of study
- Any of the following treatments for obesity within 1 year prior, or plan to undergo any of these during the study period: liposuction, cryolipolysis, or abdominoplasty
- Prior or planned bariatric or gastric sleeve surgery, endoscopic therapy, or device-based therapy for obesity
- Type 1 or Type 2 Diabetes, history of ketoacidosis, or hyperosmolar state
- Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome Type 2
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 | Other | Placebo |
Primary outcome
Change from Baseline in Total Calorie Intake at Lunch and Dinner (Combined)
Time frame: Baseline up to Week 17 (inclusive)
7 secondary outcomes
Change from Baseline in Sleep Metabolic Rate (SMR)
Time frame: Baseline up to Week 16 (inclusive)
Change from Baseline in SMR
Time frame: Baseline up to Week 16 (inclusive)
Change from Baseline in 24-hour Energy Expenditure (EE)
Time frame: Baseline up to Week 16 (inclusive)
Change from Baseline in 24-hour EE
Time frame: Baseline up to Week 16 (inclusive)
Change from Baseline in Total Calorie Intake at Lunch
Time frame: Baseline up to Week 17 (inclusive)
Change from Baseline in Total Calorie Intake at Dinner
Time frame: Baseline up to Week 17 (inclusive)
Change from Baseline in Fasting Appetite Visual Analog Score (VAS)
Time frame: Baseline up to Week 16 (inclusive)
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 23 Sep 2025.
- A Study to Measure Calorie Consumption and Usage in Participants With Obesity Using LY3437943Link provided by the sponsor.
- 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
3 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 Obesity, run by Eli Lilly and Company at 3 sites in United States.
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 2 inclusion and 13 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 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Change from Baseline in Total Calorie Intake at Lunch and Dinner (Combined) (time frame: Baseline up to Week 17 (inclusive)). 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 23 Sep 2025.