DelfaGLP-1 Atlas

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RecruitingPhase 1

A Study in People With Overweight or Obesity to Compare How 2 Different Formulations of Survodutide Are Taken up by the Body

Bioequivalence of Two Survodutide (BI 456906) Formulations Via Subcutaneous Administration After Multiple Doses (an Open-label, Randomised, Multiple-dose, Crossover Trial)

Asset

Survodutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

1

Recruiting sites

1

Enrollment

80

estimated

Study population

Obesity / overweight

Key I/E criteria

•BMI 27-39.9•Healthy volunteers

Primary endpoints

•AUC of survodutide in plasma at steady state over a uniform dosing interval tau•Maximum measured concentration of survodutide in plasma at steady state over

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07407348
Org study ID1404-0066
Secondary IDU1111-1323-8960WHO - International Clinical Trials Registry Platform (ICTRP)

Timeline

Milestones

Study first posted2026-02-12actual
Study start2026-02-26actual
Last update posted2026-03-17actual
Primary completion2027-01-26estimated
Study completion2027-03-02estimated

Assets

Investigational agents

Survodutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

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

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.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

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.

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

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

Time frame:Up to 239 days.

Cmax

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.