Comparing two survodutide formulations in adults with overweight or obesity

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

This trial tests whether two different survodutide formulations are taken up the same way in adults with overweight or obesity.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Boehringer Ingelheim (Industry-sponsored)
• Locations: 1 site (Nottingham)
• Trial ID: NCT07407348 on ClinicalTrials.gov

What this trial studies

This Phase 1 multiple-dose trial compares the pharmacokinetics and bioequivalence of formulation A and formulation B6 of survodutide in adults with overweight or obesity. Participants aged 18–65 with a BMI of 27.0–39.9 kg/m2 who are judged healthy by the investigator will receive repeated doses and undergo blood sampling and clinical assessments to measure drug uptake. The trial is sponsored by Boehringer Ingelheim and conducted at Quotient Sciences in Nottingham. Results will determine whether the two formulations produce similar systemic exposure.

Who should consider this trial

Good fit: Adults 18–65 years old with a BMI between 27.0 and 39.9 kg/m2 who are otherwise healthy and agree to protocol requirements (including required contraception for women of childbearing potential) are eligible.

Not a fit: People outside the specified age or BMI ranges, those with significant health conditions, or pregnant or breastfeeding women are unlikely to benefit from participating in this trial.

Why it matters

Potential benefit: If the two formulations are bioequivalent, patients could have access to an alternative survodutide formulation that provides similar drug exposure.

How similar studies have performed: Bioequivalence studies are a common step in developing peptide therapies and similar pharmacokinetic comparisons have been successfully used for other injectable metabolic drugs, though survodutide-specific data are limited.

Eligibility criteria

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.

Where this trial is running

Nottingham

• Quotient Sciences — Nottingham, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Boehringer Ingelheim

Conditions Healthy; Obesity; Overweight