Type 2 Diabetes MellitusPhase 1NCT06982846
A Study to Investigate the Response of Participants With Type 2 Diabetes Mellitus on Once-Weekly Retatrutide to Hypoglycemia
A Phase 1 study testing Retatrutide in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 1 site in Austria.
Trial summary
The purpose of this study is to measure the effect of retatrutide versus placebo, administered every week, on time to recovery from hypoglycemia during hypoglycemic clamp in participants with Type 2 Diabetes Mellitus (T2DM) following 16 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Retatrutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- 6 Jun 2025to 4 May 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have been diagnosed with T2DM for at least 6 months prior to screening.
- Treated with diet and exercise and stable treatment with metformin with or without 1 additional allowed oral antihyperglycemic medications (OAM), 3 months prior to screening.
- Treatment with metformin will be considered stable if all prescribed total daily doses for this period were ±850 mg from the original prescription for the same participant.
- Allowed OAMs include dipeptidyl peptidase-4 (DPP-IV) inhibitors, sodium-glucose co-transporter-2 (SGLT2) inhibitors, glinides, or sulfonylureas.
- Have a hemoglobin A1c value at screening of
- ≥6.0% (≥ 42 millimole per liter(mmol/L)) and ≤9.5% (≤80 mmol/L) if on metformin only or
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- ≥6.0% (≥42 mmol/L) and ≤8.5% (≤69 mmol/L) if on metformin in combination with 1 additional allowed OAM.
- Have a BMI within the range 25.0 kg/m2 and 45.0 kg/m2 kg/m2 (both inclusive).
- Have had a stable body weight that is less than 5% change in body weight for more than 3 months prior to screening.
Who cannot join
- Have Type 1 diabetes mellitus.
- Have had more than 1 episode of severe hypoglycemia, as defined by the American Diabetes Association criteria, within 6 months before screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
- Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalization within the 6 months prior to screening.
- Have impaired renal estimated glomerular filtration rate <60 mL/min/1.73 m2 calculated by Chronic Kidney Disease-Epidemiology.
- Have acute or chronic pancreatitis or a history of acute idiopathic pancreatitis.
- Have elevations in
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- serum aspartate aminotransferase (AST) >2.5× upper limit normal (ULN)
- serum alanine aminotransferase (ALT) >2.5×ULN
- total bilirubin level (TBL) >1.5×ULN, or
- alkaline phosphatase (ALP) level ≥1.5× ULN.
- Have a known clinically significant gastric emptying abnormality.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-Controlled, Parallel Study to Investigate the Response of Participants With Type 2 Diabetes Mellitus on Once-Weekly Retatrutide to Hypoglycemia
The purpose of this study is to measure the effect of retatrutide versus placebo, administered every week, on time to recovery from hypoglycemia during hypoglycemic clamp in participants with Type 2 Diabetes Mellitus (T2DM) following 16 weeks of treatment.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Retatrutide, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RetatrutideDrug
Also called LY3437943
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Retatrutide | Experimental | Participants will receive escalated doses of retatrutide administered subcutaneously (SC) every week (QW) until reaching target dose. Receives: Drug: Retatrutide |
| Placebo | Placebo comparator | Participants will receive matching placebo administered SC QW. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-Event of Recovery of Plasma Glucose (PG) Concentration from 48 Milligram per Deciliter (48 mg/dL) to 70 mg/dL (tPG_nadir-70 mg/dL)
Time-to-event of recovery of PG concentration from 48 mg/dL to 70 mg/dL.
Measured: Within 60 minutes after nadir
Secondary outcomes (4)
Time to Reach Recovery of Plasma Glucose (PG) Concentration from 48 mg/dL to 70 mg/dL (tPG_nadir-70 mg/dL) Including Recovery Beyond 60 Minutes.
Time-to-event of recovery of PG concentration from 48 mg/dL to 70 mg/dL including recovery beyond 60 minutes.
Measured: Beyond 60 minutes after nadir
Percentage of Participants Who Require Rescue Glucose Infusion to Attain Recovery PG Concentration of 70 mg/dL
Percentage of participants who require rescue glucose infusion to attain recovery PG concentration of 70 mg/dL.
Measured: Up to 60 minutes after nadir
Hypoglycemic Symptoms Score at set PG Concentration Points
Hypoglycemia symptoms were measured with the Edinburgh Hypoglycemia Symptom Scale (EHSS) where lower scores indicate fewer symptoms.
Measured: Day 114 during hypoglycemic clamp
Percentage of Participants Who Experienced Hypoglycemic Awareness at Set PG Points
Percentage of participants who experienced hypoglycemic awareness at set PG points.
Measured: Day 114 during hypoglycemic clamp
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start6 Jun 2025
- Primary completion4 May 2026
- Study completion4 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- 80 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 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982846
- Sponsor's protocol ID
- 27316
- Other IDs
- J1I-MC-GZQF, 2024-518471-63-00
- Status last verified
- Jun 2026
- First submitted
- 14 May 2025
- Last updated
- 18 Jun 2026
- 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 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Parallel Study to Investigate the Response of Participants With Type 2 Diabetes Mellitus on Once-Weekly Retatrutide to Hypoglycemia
- ClinicalTrials.gov ID
- NCT06982846
- Acronym / sponsor ID
- 27316
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 4 May 2026 (actual)
- Study completion
- 4 May 2026 (actual)
- First posted
- 21 May 2025 (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 measure the effect of retatrutide versus placebo, administered every week, on time to recovery from hypoglycemia during hypoglycemic clamp in participants with Type 2 Diabetes Mellitus (T2DM) following 16 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retatrutide | Experimental | Drug: RetatrutideParticipants will receive escalated doses of retatrutide administered subcutaneously (SC) every week (QW) until reaching target dose. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo administered SC QW. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have been diagnosed with T2DM for at least 6 months prior to screening.
- Treated with diet and exercise and stable treatment with metformin with or without 1 additional allowed oral antihyperglycemic medications (OAM), 3 months prior to screening.
- Have a hemoglobin A1c value at screening of
- Have a BMI within the range 25.0 kg/m2 and 45.0 kg/m2 kg/m2 (both inclusive).
- Have had a stable body weight that is less than 5% change in body weight for more than 3 months prior to screening.
Key exclusion criteria (11 listed)
- Have Type 1 diabetes mellitus.
- Have had more than 1 episode of severe hypoglycemia, as defined by the American Diabetes Association criteria, within 6 months before screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
- Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalization within the 6 months prior to screening.
- Have impaired renal estimated glomerular filtration rate <60 mL/min/1.73 m2 calculated by Chronic Kidney Disease-Epidemiology.
- Have acute or chronic pancreatitis or a history of acute idiopathic pancreatitis.
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 |
|---|---|---|
| RetatrutideAlso: LY3437943Administered SC | Drug | Retatrutide |
| PlaceboAdministered SC | Drug | Placebo |
Primary outcome
Time-to-Event of Recovery of Plasma Glucose (PG) Concentration from 48 Milligram per Deciliter (48 mg/dL) to 70 mg/dL (tPG_nadir-70 mg/dL)
Time frame: Within 60 minutes after nadir
Time-to-event of recovery of PG concentration from 48 mg/dL to 70 mg/dL.
4 secondary outcomes
Time to Reach Recovery of Plasma Glucose (PG) Concentration from 48 mg/dL to 70 mg/dL (tPG_nadir-70 mg/dL) Including Recovery Beyond 60 Minutes.
Time frame: Beyond 60 minutes after nadir
Percentage of Participants Who Require Rescue Glucose Infusion to Attain Recovery PG Concentration of 70 mg/dL
Time frame: Up to 60 minutes after nadir
Hypoglycemic Symptoms Score at set PG Concentration Points
Time frame: Day 114 during hypoglycemic clamp
Percentage of Participants Who Experienced Hypoglycemic Awareness at Set PG Points
Time frame: Day 114 during hypoglycemic clamp
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 18 Jun 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. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
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 Retatrutide in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 1 site in Austria.
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 11 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 18 Jun 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 Austria. 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?
Time-to-Event of Recovery of Plasma Glucose (PG) Concentration from 48 Milligram per Deciliter (48 mg/dL) to 70 mg/dL (tPG_nadir-70 mg/dL) (time frame: Within 60 minutes after nadir). 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 18 Jun 2026.