GLP-1 Peptide Atlas, by Delfa

Not yet recruitingPhase 2

Safety and Efficacy of NA-931 and Tirzepatide in Adults Who Are Overweight or Obese

A Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of Oral NA-931, Alone or in Addition to Open Label Subcutaneous Tirzepatide , to Investigate the Efficacy and Safety in Overweight or Obese Men and Women

Lead sponsor

Biomed Industries, Inc.

Assets

GLP-1 / incretin class catch-all / NA-931 / Tirzepatide

Listed sites

Recruiting sites

—

Enrollment

224

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoint

•Body weight, absolute change (kg)

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 IDNCT06732245

Org study IDNA-931-200

Timeline

Milestones

Study first posted2024-12-13actual

Last update posted2026-03-27actual

Study start2026-08-15estimated

Primary completion2027-08-15estimated

Study completion2027-12-15estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all NA-931 Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age19 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•A written informed consent must be obtained before any study-related assessments are performed.

•Men and women between 18 and 80 years, inclusive; women of child-bearing potential (defined as those who are not post-menopausal or post-surgical sterilization) must meet both of the following criteria:

–Two negative pregnancy tests (at screening and at randomization, prior to dosing)

–Use of intrauterine device, from at least 3 months before the baseline visit through at least 4 months after the last dose of NA-931/placebo oral, and an additional contraceptive (barrier) method from screening through at least 4 months after the last dose of NA-931/placebo oral.

•Body mass index (BMI) ≥ 30 or BMI ≥ 27 with one or more obesity-associated comorbidities (e.g., hypertension, insulin resistance, sleep apnea, or dyslipidemia)

•Stable body weight (± 5 kg) within 90 days of screening, and body weight <150 kg

•Have a history of at least one self-reported unsuccessful behavioral effort to lose body weight

•Able to communicate well with the Investigator, comply with the study requirements and adhere to the diet and activity programs for the study duration

Exclusion criteria

•• History of, or known hypersensitivity to, monoclonal antibody drugs or a contraindication to Tirzepatide (Zepbound® or Mounjaro®)

–Use of other investigational drugs at the time of enrollment or within 30 days or 5 half-lives of enrollment, whichever is longer, or longer if required by local regulations

–Treatment with any medication for the indication of obesity within the past 30 days before screening

–Diagnosis of diabetes requiring current use of any antidiabetic drug or HbA1c ≥ 6.5% Note: Metabolic syndrome is not an exclusion, even if managed with an anti-diabetic drug such as metformin or an SGLT2 inhibitor. A diagnosis of prediabetes or impaired glucose tolerance managed exclusively with non-pharmacologic approaches (e.g., diet and exercise) is not an exclusion.

–Any chronic infections likely to interfere with study conduct or interpretation such as hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV). History of hepatitis A or hepatitis C successfully treated is not exclusionary. Active COVID-19 infection.

–Donation or loss of 400 mL or more of blood within 8 weeks prior to initial dosing, or longer if required by local regulation, or plasma donation (> 250 mL) within 14 days prior to the first dose

–Any disorder, unwillingness, or inability not covered by any of the other exclusion criteria, which in the Investigator's opinion, might jeopardize the participant's safety or compliance with the protocol

Endpoints (19)

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.

Coverage by outcome category

Weight & body composition

Patient-reported / QoL

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

15 endpoints

Primary/protocol endpoint

Change from baseline in body weight at 48 weeks

Time frame:48 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in waist circumference (cm) at 48 weeks

Time frame:48 weeks

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline at 48 weeks in total body fat mass in kilograms (kg)

Time frame:48 weeks

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline at 48 weeks in percent body fat

Time frame:48 weeks

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline at 48 weeks in visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT) and trunk fat mass by dual-energy x-ray absorptiometry (DXA)

Time frame:48 weeks

Total fat mass

change from baseline, improvement

componentsVisceral fat, change, Subcutaneous fat, change, Total fat mass

Secondary/protocol endpoint

Proportion of participants at 48 weeks with change in waist circumference ≥ 5 cm

Time frame:48 weeks

Waist circumference, change

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of participants at 48 weeks with change in Body weight ≥ 5%, ≥ 10% and ≥15%

Time frame:48 weeks

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of participants at 48 weeks with change in Fat mass ≥ 5% ≥ 10% ≥ 15% by Dual energy X-ray absorptiometry (DXA)

Time frame:48 weeks

Total fat mass

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of participants at 48 weeks with change in Fat mass ≥ 10% with <5% decrease (or and increase) in lean mass by Dual energy X-ray absorptiometry (DXA)

Time frame:48 weeks

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Percentage of weight loss due to fat mass or lean mass at 48 weeks by dual-energy x-ray absorptiometry (DXA)

Time frame:48 weeks

percent change from baseline, improvement

Secondary/protocol endpoint

Change from baseline at 48 weeks in fat mass (kg and %) by bioelectrical impedance analysis (BIA)

Time frame:48 weeks

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline at 48 weeks in lean mass (kg and %) and appendicular lean mass by dual-energy x-ray absorptiometry (DXA)

Time frame:48 weeks

Lean mass

change from baseline, improvement

componentsLean mass

Secondary/protocol endpoint

Change from baseline at 48 weeks in lean mass (kg) by bioelectrical impedance analysis (BIA)

Time frame:48 weeks

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Proportion of Participants with change from baseline in Body Mass Index (BMI) categories at 48 weeks

Time frame:48 weeks

categorical status, improvement

Secondary/protocol endpoint

Proportion of Participants with change from baseline in waist-to-height ratio (WHtR ratio) categories at 48 weeks

Time frame:48 weeks

threshold achievement, improvement

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Change from baseline in HbA1c (mmol/mol) at 48 weeks

Time frame:48 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Patient-reported / QoL

2 endpoints

Secondary/protocol endpoint

Change from baseline at 48 weeks in Quality of Life Short Form 36 (SF-36) survey

Time frame:48 weeks

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline at 48 weeks in Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite)

Time frame:48 weeks

IWQOL-Lite total

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Safety and tolerability measurements throughout 48 weeks by TEAEs [safety labs, vital signs]

Time frame:48 weeks

Treatment-emergent AEs (any)

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.