CClinicalTrials.gg
Active, not recruitingNCT07407348Updated Sep 9, 2026

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 interventional study of Formulation A and Formulation B6 in Healthy, Obesity and Overweight, sponsored by Boehringer Ingelheim. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
  • Obesity
  • Overweight
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 80 is close to the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 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
  2. Age of 18 to 65 years (inclusive)
  3. Body Mass Index (BMI) of 27.0 to 39.9 Kg/ m\^2 (inclusive)
  4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
  5. 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)
    • 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

Exclusion criteria

Exclusion Criteria:

  1. Any finding in the medical examination (including BP, PR) or ECG) deviating from normal and assessed as clinically relevant by the investigator
  2. 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
  3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
  4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator.
  5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
  6. 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
  7. History of relevant orthostatic hypotension, fainting spells, or blackouts
  8. Relevant chronic or acute infections within the 4 weeks prior to screening Further exclusion criteria apply.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Formulation A, then Formulation B6

    Combination Product: Formulation A · Combination Product: Formulation B6

  • Experimental
    Formulation B6, then Formulation A

    Combination Product: Formulation A · Combination Product: Formulation B6

Interventions

  • Combination productFormulation A

    Formulation A of survodutide

  • Combination productFormulation B6

    Formulation B6 of survodutide

06

What researchers measure

Primary outcomes

  1. 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.

  2. Maximum measured concentration of survodutide in plasma at steady state over a uniform dosing interval tau (Cmax,ss)

    Time frame: Up to 239 days.

07

Study locations

1 site
  • Quotient Sciences
    Nottingham, NG11 6JS, United Kingdom
08

References and documents

Individual participant data

Plan to share: 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

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07407348
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Feb 12, 2026
Start date
Mar 11, 2026
Primary completion
Jan 26, 2027 (estimated)
Completion
Mar 2, 2027 (estimated)
Last update
Sep 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion