HealthyPhase 1NCT07407348
A Study in People With Overweight or Obesity to Compare How 2 Different Formulations of Survodutide Are Taken up by the Body
A Phase 1 study testing Formulation A and Formulation B6 in people with Healthy and Obesity, run by Boehringer Ingelheim at 1 site in United Kingdom.
Trial summary
The primary objective of this trial is to assess bioequivalence of two formulations of survodutide (formulation A and formulation B6) after multiple-dose treatment in male and female trial participants living with overweight or obesity. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Obesity, Overweight
- What is being tested?
- Formulation A and Formulation B6
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Mar 2026to 2 Mar 2027
- 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
- Healthy male or female trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
- Age of 18 to 65 years (inclusive)
- Body Mass Index (BMI) of 27.0 to 39.9 Kg/ m^2 (inclusive)
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- For women of child-bearing potential (WOCBP) trial participants: Woman of childbearing potential (WOCBP) trial participants who meet any of the following criteria for a highly effective contraception from at least 28 days before the first administration of trial medication until 28 days after trial completion:
- Use of combined (estrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal or transdermal). In case of oral contraception, a barrier method should be used in addition or advised to change to non-oral contraceptives at least 7 days prior to first dose of investigational medicine product (IMP)
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- Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants). In case of oral contraception, a barrier method should be used in addition or advised to change to non-oral contraceptives at least 7 days prior to first dose of IMP
- Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
- Complete abstinence (refraining from heterosexual intercourse during the entire period of risk associated with the study treatment) is considered a highly effective method of contraception only if it is in line with the preferred and usual lifestyle of the trial participant. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to trial IMP, spermicides only, lactational amenorrhoea method (LAM) and withdrawal are not acceptable methods of contraception
- Bilateral tubal ligation/occlusion is considered a highly effective method of contraception, provided that the procedure has not been reversed or failed.
- Surgically sterilised (including hysterectomy, bilateral salpingectomy and bilateral oophorectomy)
- Postmenopausal, defined as no menses for 1 year without an alternative medical cause
Who cannot join
- Any finding in the medical examination (including BP, PR) or ECG) deviating from normal and assessed as clinically relevant by the investigator
- Repeated measurement of systolic Blood pressure (BP) outside the range of 90 to 150 mmHg, diastolic BP outside the range of 50 to 100 mmHg, or PR outside the range of 50 to 100 bpm
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator.
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
- Diseases of the Central nervous system (CNS) (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Relevant chronic or acute infections within the 4 weeks prior to screening Further exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioequivalence of Two Survodutide (BI 456906) Formulations Via Subcutaneous Administration After Multiple Doses (an Open-label, Randomised, Multiple-dose, Crossover Trial)
The primary objective of this trial is to assess bioequivalence of two formulations of survodutide (formulation A and formulation B6) after multiple-dose treatment in male and female trial participants living with overweight or obesity.
- Conditions
- Healthy, Obesity, Overweight
- Being tested
- Formulation A, Formulation B6
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formulation ACombination product
Formulation A of survodutide
Formulation B6Combination product
Formulation B6 of survodutide
| Study group | Role | What they receive |
|---|---|---|
| Formulation A, then Formulation B6 | Experimental | Not described Receives: Combination Product: Formulation A; Combination Product: Formulation B6 |
| Formulation B6, then Formulation A | Experimental | Not described Receives: Combination Product: Formulation A; Combination Product: Formulation B6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of survodutide in plasma at steady state over a uniform dosing interval tau (AUC tau,ss)
Measured: Up to 239 days.
Maximum measured concentration of survodutide in plasma at steady state over a uniform dosing interval tau (Cmax,ss)
Measured: Up to 239 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start11 Mar 2026
- Primary completion26 Jan 2027 (estimated)
- Study completion2 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407348
- Sponsor's protocol ID
- 1404-0066
- Other IDs
- U1111-1323-8960
- Status last verified
- Sep 2026
- First submitted
- 6 Feb 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence of Two Survodutide (BI 456906) Formulations Via Subcutaneous Administration After Multiple Doses (an Open-label, Randomised, Multiple-dose, Crossover Trial)
- ClinicalTrials.gov ID
- NCT07407348
- Acronym / sponsor ID
- 1404-0066
- Conditions
- Healthy, Obesity, Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- 26 Jan 2027 (estimated)
- Study completion
- 2 Mar 2027 (estimated)
- First posted
- 12 Feb 2026 (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 primary objective of this trial is to assess bioequivalence of two formulations of survodutide (formulation A and formulation B6) after multiple-dose treatment in male and female trial participants living with overweight or obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formulation A, then Formulation B6 | Experimental | Combination Product: Formulation A, Combination Product: Formulation B6 |
| Formulation B6, then Formulation A | Experimental | Combination Product: Formulation A, Combination Product: Formulation B6 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Healthy male or female trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
- Age of 18 to 65 years (inclusive)
- Body Mass Index (BMI) of 27.0 to 39.9 Kg/ m^2 (inclusive)
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- For women of child-bearing potential (WOCBP) trial participants: Woman of childbearing potential (WOCBP) trial participants who meet any of the following criteria for a highly effective contraception from at least 28 days before the first administration of trial medication until 28 days after trial completion:
Key exclusion criteria (8 listed)
- Any finding in the medical examination (including BP, PR) or ECG) deviating from normal and assessed as clinically relevant by the investigator
- Repeated measurement of systolic Blood pressure (BP) outside the range of 90 to 150 mmHg, diastolic BP outside the range of 50 to 100 mmHg, or PR outside the range of 50 to 100 bpm
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator.
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
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 |
|---|---|---|
| Formulation AFormulation A of survodutide | Combination product | Formulation A, then Formulation B6, Formulation B6, then Formulation A |
| Formulation B6Formulation B6 of survodutide | Combination product | Formulation A, then Formulation B6, Formulation B6, then Formulation A |
Primary outcome
Area under the concentration-time curve of survodutide in plasma at steady state over a uniform dosing interval tau (AUC tau,ss)
Time frame: Up to 239 days.
Maximum measured concentration of survodutide in plasma at steady state over a uniform dosing interval tau (Cmax,ss)
Time frame: Up to 239 days.
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 Sep 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Formulation A and Formulation B6 in people with Healthy and Obesity, run by Boehringer Ingelheim at 1 site in United Kingdom.
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 12 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 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 United Kingdom. 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. 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?
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?
Area under the concentration-time curve of survodutide in plasma at steady state over a uniform dosing interval tau (AUC tau,ss) (time frame: Up to 239 days.). The study lists 2 primary outcomes in all. 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 Sep 2026.